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 Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use| Primary Device ID | 00850004312001 |
| NIH Device Record Key | ec03b20e-6c7e-4abb-a2bc-86f5a1d7987a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING |
| Version Model Number | 668782-100 |
| Catalog Number | PN1007960-100 |
| Company DUNS | 790487263 |
| Company Name | FREUDENBERG MEDICAL, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
| Catheter Gauge | 21 French |
| Catheter Working Length | 56 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Lumen/Inner Diameter | 7 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850004312001 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K190628
FDA Product Code
| DYB | Introducer, Catheter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-23 |
| Device Publish Date | 2021-06-15 |
Devices Manufactured by FREUDENBERG MEDICAL, LLC
| 00848253002347 - InHealth Technologies; Blom-Singer | 2023-11-13 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 98599180 not registered Live/Pending |
Empower Aesthetics LLC 2024-06-13 |
 EMPOWER 98429101 not registered Live/Pending |
MFB Fertility, Inc. 2024-03-01 |
 EMPOWER 98347068 not registered Live/Pending |
The Tranzonic Companies 2024-01-08 |
 EMPOWER 98323385 not registered Live/Pending |
Jose Ramos 2023-12-20 |
 EMPOWER 97933490 not registered Live/Pending |
Brex Inc. 2023-05-12 |
 EMPOWER 97895669 not registered Live/Pending |
empowerHER, Inc. 2023-04-19 |
 EMPOWER 97853261 not registered Live/Pending |
RPX Corporation 2023-03-23 |
 EMPOWER 97693845 not registered Live/Pending |
ELEVAI LABS INC. 2022-11-28 |
 EMPOWER 97570865 not registered Live/Pending |
Thoughtful Automation Inc. 2022-08-30 |
 EMPOWER 97558286 not registered Live/Pending |
AvePoint, Inc. 2022-08-22 |
 EMPOWER 97476672 not registered Live/Pending |
Metropolitan District of The Christian and Missionary Alliance 2022-06-27 |
 EMPOWER 97475164 not registered Live/Pending |
JJ Acquisition, LLC 2022-06-24 |
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