AccessGUDID - DEVICE: OmniTrustTM (00810572006108)

GUDID

Device Identifier (DI) Information

Brand Name: OmniTrustTM
Version or Model: 9012-43
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9012-43
Company Name: OMNI INTERNATIONAL CORP.

Primary DI Number: 00810572006108
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 200
Labeler D-U-N-S® Number*: 079434709 *Terms of Use

Device Description: Gauze Sponge, Non-Sterile, 4x4, 8 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):	No
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?
48133	Woven gauze pad, non-sterile	A non-medicated, non-sterile device in the form of a patch or swab (also referred to as a sponge) made from woven material (e.g., cotton, cellulose) and primarily designed to absorb fluids for medical purposes; it does not include petrolatum. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications. 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
Length: 4 Inch
Width: 4 Inch

Device Record Status

Public Device Record Key: b34dbeed-effc-4d1d-8f70-e0eb5b4338e9
Public Version Date: September 04, 2019
Public Version Number: 1
DI Record Publish Date: August 27, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
50810572006103	20	00810572006108		In Commercial Distribution	Shipper Carton

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 10810572006105 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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(603)471-1499
Email: Info@Omnigloves.com

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