AccessGUDID - DEVICE: Krinkle Gauze Roll, Non-Sterile (00616784316239)

GUDID

Device Identifier (DI) Information

Brand Name: Krinkle Gauze Roll, Non-Sterile
Version or Model: 3162
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Dynarex Corporation

Primary DI Number: 00616784316239
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 008124539 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
48126	Woven gauze roll, non-sterile	A non-sterile device in the form of a long strip of stretchable, absorbent, woven material (e.g., cotton, cellulose), wound into a roll, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, injury padding and compression. It is not a dedicated pressure dressing and does not include latex. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
NAB	Gauze / Sponge,Nonresorbable For External Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 29d49477-3ff2-43bd-897a-c7b4df5c6062
Public Version Date: October 09, 2024
Public Version Number: 2
DI Record Publish Date: June 21, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 00616784316222 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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