DinamicOR

GUDID 10810101311151

DinamicOR Procedure Fee with Triple-Wide Sterile Table Cover 10/case

Paneffort, LLC

Medical equipment/instrument drape, single-use
Primary Device ID10810101311151
NIH Device Record Keyaa0f7b7e-c3c7-4f32-96c5-42a2f96968e8
Commercial Distribution StatusIn Commercial Distribution
Brand NameDinamicOR
Version Model Number111-3223d
Company DUNS018250858
Company NamePaneffort, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone585-433-8080
Emailcustomerservice@dinamicor.com
Phone585-433-8080
Emailcustomerservice@dinamicor.com
Phone585-433-8080
Emailcustomerservice@dinamicor.com
Phone585-433-8080
Emailcustomerservice@dinamicor.com
Phone585-433-8080
Emailcustomerservice@dinamicor.com
Phone585-433-8080
Emailcustomerservice@dinamicor.com
Phone585-433-8080
Emailcustomerservice@dinamicor.com
Phone585-433-8080
Emailcustomerservice@dinamicor.com
Phone585-433-8080
Emailcustomerservice@dinamicor.com
Phone585-433-8080
Emailcustomerservice@dinamicor.com
Phone585-433-8080
Emailcustomerservice@dinamicor.com
Phone585-433-8080
Emailcustomerservice@dinamicor.com
Phone585-433-8080
Emailcustomerservice@dinamicor.com
Phone585-433-8080
Emailcustomerservice@dinamicor.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100810101311154 [Primary]
GS110810101311151 [Package]
Contains: 00810101311154
Package: Case [10 Units]
In Commercial Distribution

FDA Product Code

PUIDrape, Surgical, Exempt

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-20
Device Publish Date2025-06-12

On-Brand Devices [DinamicOR]

10810101311113DinamicOR Procedure Fee with Double-Wide Sterile Table Cover 12/case
10810101310369DinamicOR Procedure Fee with Triple-Wide Sterile Table Cover 10/case
10810101311151DinamicOR Procedure Fee with Triple-Wide Sterile Table Cover 10/case
00810101311147DinamicOR Procedure Fee with Double-Wide Sterile Table Cover 12/case

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.