Adhesive Tape Remover Pads, For Professional and Hospital Use

GUDID 00616784150529

Dynarex Corporation

Patient medical adhesive remover
Primary Device ID00616784150529
NIH Device Record Keyb72bfa95-b2b5-4eea-9356-a79b20589f25
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdhesive Tape Remover Pads, For Professional and Hospital Use
Version Model Number1505
Company DUNS008124539
Company NameDynarex Corporation
Device Count100
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100616784150529 [Primary]
GS100616784150536 [Package]
Package: Case [10 Units]
In Commercial Distribution
GS100810180842297 [Unit of Use]

FDA Product Code

KOYDegreaser, Skin, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-10-06
Device Publish Date2025-09-26

Devices Manufactured by Dynarex Corporation

00616784345512 - Durma+ Unna Boot Bandage with Zinc Oxide and Calamine 2025-12-26 Size: 3" x 10 yd. (7.6 cm x 9.1m)
00616784345611 - Durma+ Unna Boot Bandage with Zinc Oxide and Calamine 2025-12-26 Size: 4" x 10 yd. (10.2 cm x 9.1m)
00616784345314 - Durma+ Unna Boot Bandage with Zinc Oxide2025-12-25 3" x 10" yd (7.6 cm x 9.1 m)
00616784345437 - Durma+ Unna Boot Bandage with Zinc Oxide2025-12-25 4" x 10 yd (10.2 cm x 9.1m)
00840117345751 - Durma+ SiliGentle Silicone Foam Dressing, Bordered2025-12-18 4" x 8" (10,cm x 20,3 cm) , STERILE-EO
00840117345782 - Durma+ SiliGentle Silicone Foam Dressing, Bordered2025-12-18 8" x 8" (20,3 cm x 20,3 cm), STERILE-EO
00840117345812 - Durma+ SiliGentle Silicone Foam Dressing, Bordered2025-12-18 8" x 6" (20,3 cm x 15,2 cm), STERILE-EO
00840117345539 - Durma+ Y-Type Suction Drainage Tube, 10 Fr 2025-12-02

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