EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING PN1007960-100

GUDID 00850004312001

The EMPOWER™ Introducer Sheath with Hydrophilic Coating consists of a single-use disposable introducer sheath and dilator that is inserted into the peripheral vasculature to support the introduction of diagnostic or interventional devices, while minimizing blood loss associated with such insertions. The EMPOWER™ Introducer Sheath is coil-reinforced and coated with a lubricious hydrophilic coating. The EMPOWER™ hemostasis valve is integrated into the sheath hub and features a variable aperture seal for enhanced control over device insertion while maintaining hemostasis. The valve is normally closed until the user squeezes the actuator levers to proportionally open the valve and receive any device up to its labeled size. A sideport extends from the EMPOWER™ valve housing with a 3-way stopcock. The radiopaque dilator is designed to accommodate an .035” (0.89mm) guidewire and includes a proximal hub grip with a female luer taper fitting for flushing. Prior to insertion, the dilator hub can be secured to the EMPOWER™ housing with a quarter-turn twist.

FREUDENBERG MEDICAL, LLC

Vascular dilator, single-use
Primary Device ID00850004312001
NIH Device Record Keyec03b20e-6c7e-4abb-a2bc-86f5a1d7987a
Commercial Distribution StatusIn Commercial Distribution
Brand NameEMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING
Version Model Number668782-100
Catalog NumberPN1007960-100
Company DUNS790487263
Company NameFREUDENBERG MEDICAL, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
Phone812-280-2400
EmailDL-Corp-UniqueDeviceIndicator@freudenbergmedical.com

Device Dimensions

Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter
Catheter Gauge21 French
Catheter Working Length56 Centimeter
Guidewire Diameter0.035 Inch
Lumen/Inner Diameter7 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.

Device Identifiers

Device Issuing AgencyDevice ID
GS100850004312001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYBIntroducer, Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-23
Device Publish Date2021-06-15

Devices Manufactured by FREUDENBERG MEDICAL, LLC

00848253002347 - InHealth Technologies; Blom-Singer2023-11-13 Blom-Singer® FirstFit Surgical Kit with 16Fr Classic Indwelling Voice Prosthesis, 8mm length
00848253002354 - InHealth Technologies; Blom-Singer®2023-11-13 Blom-Singer® FirstFit Surgical Kit with 16Fr Classic Indwelling Voice Prosthesis, 10mm length
00848253002361 - InHealth Technologies; Blom-Singer®2023-11-13 Blom-Singer® FirstFit Surgical Kit with 16Fr Classic Indwelling Voice Prosthesis, 12mm length
00848253002378 - InHealth Technologies; Blom-Singer®2023-11-13 Blom-Singer® FirstFit Surgical Kit with 16Fr Classic Indwelling Voice Prosthesis, 14mm length
00848253002385 - InHealth Technologies; Blom-Singer®2023-11-13 Blom-Singer® FirstFit Surgical Kit with 20Fr Classic Indwelling Voice Prosthesis, 8mm length
00848253002408 - InHealth Technologies; Blom-Singer®2023-11-13 Blom-Singer® FirstFit Surgical Kit with 20Fr Classic Indwelling Voice Prosthesis, 10mm length
00848253002606 - InHealth Technologies; Blom-Singer®2023-11-13 Blom-Singer® FirstFit Surgical Kit with 20Fr Classic Indwelling Voice Prosthesis, 12mm length
00848253003092 - InHealth Technologies; Blom-Singer®2023-11-13 Blom-Singer® FirstFit Surgical Kit with 20Fr Classic Indwelling Voice Prosthesis, 14mm length

Trademark Results [EMPOWER]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EMPOWER
EMPOWER
98774537 not registered Live/Pending
W4 Health Group, Inc.
2024-09-27
EMPOWER
EMPOWER
98725951 not registered Live/Pending
Kiss Nail Products, Inc.
2024-08-30
EMPOWER
EMPOWER
98599180 not registered Live/Pending
Empower Aesthetics LLC
2024-06-13
EMPOWER
EMPOWER
98429101 not registered Live/Pending
MFB Fertility, Inc.
2024-03-01
EMPOWER
EMPOWER
98347068 not registered Live/Pending
The Tranzonic Companies
2024-01-08
EMPOWER
EMPOWER
98323385 not registered Live/Pending
Jose Ramos
2023-12-20
EMPOWER
EMPOWER
97933490 not registered Live/Pending
Brex Inc.
2023-05-12
EMPOWER
EMPOWER
97895669 not registered Live/Pending
empowerHER, Inc.
2023-04-19
EMPOWER
EMPOWER
97853261 not registered Live/Pending
RPX Corporation
2023-03-23
EMPOWER
EMPOWER
97693845 not registered Live/Pending
ELEVAI LABS INC.
2022-11-28
EMPOWER
EMPOWER
97570865 not registered Live/Pending
Thoughtful Automation Inc.
2022-08-30
EMPOWER
EMPOWER
97558286 not registered Live/Pending
AvePoint, Inc.
2022-08-22

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