Krinkle Gauze Roll, Non-Sterile

GUDID 00616784316222

Krinkle Gauze Roll, Non-Sterile 4.5"x4.1yd, 6-ply

DYNAREX CORPORATION

Woven gauze roll, non-sterile
Primary Device ID00616784316222
NIH Device Record Key29d49477-3ff2-43bd-897a-c7b4df5c6062
Commercial Distribution StatusIn Commercial Distribution
Brand NameKrinkle Gauze Roll, Non-Sterile
Version Model Number3162
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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100616784316222 [Unit of Use]
GS100616784316239 [Primary]

FDA Product Code

NABGauze / Sponge,Nonresorbable For External Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-29
Device Publish Date2021-06-21

On-Brand Devices [Krinkle Gauze Roll, Non-Sterile]

00616784316222Krinkle Gauze Roll, Non-Sterile 4.5"x4.1yd, 6-ply
00810180844086Krinkle Gauze Roll, Non-Sterile 4.5"x4.1yd, 6-ply

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.