AccessGUDID - DEVICE: CVS Health (00050428369173)

GUDID

Device Identifier (DI) Information

Brand Name: CVS Health
Version or Model: 893128
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Primary DI Number: 00050428369173
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 062312574 *Terms of Use

Device Description: Premium Roll Gauze, 5 rolls, 3 IN x 2.1 YDS (7.6 cm x 1.9 m) Unstretched

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):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
48127	Woven gauze roll/sheet	A device in the form of a long length of stretchable, absorbent, woven material (e.g., cotton, cellulose), wound into a roll or folded, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, and injury padding and compression. It is not a dedicated pressure dressing and does not include latex. This is a single-use device.	Active	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: Yes
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: d36c6d2a-db3e-4a6d-b7c1-cea2d8a852b5
Public Version Date: April 04, 2023
Public Version Number: 3
DI Record Publish Date: August 24, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20050428369177	36	00050428369173		In Commercial Distribution	case

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 60050428369175 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: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 18007467287
Email: xx@xx.xx

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