AccessGUDID - DEVICE: GAMMEX (15414566642703)

GUDID

Device Identifier (DI) Information

Brand Name: GAMMEX
Version or Model: 340064070
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 340064070
Company Name: Ansell Healthcare Product

Primary DI Number: 15414566642703
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 111267330 *Terms of Use

Device Description: GAMMEX® PI Ergo-Fit Size 7, Sterile Polyisoprene Powder-Free Surgical Glove

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?
56293	Polyisoprene surgical glove, non-powdered, non-antimicrobial	A device made of polyisoprene intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. It is used mainly as a two-way barrier to protect patient and staff from microorganisms and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide adequate conditions of sterility, appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGO	Surgeon'S Gloves

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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
Device Size Text, specify: 7

Device Record Status

Public Device Record Key: 0ca41d79-3999-4d33-9f34-2f44eca27f8d
Public Version Date: February 28, 2022
Public Version Number: 1
DI Record Publish Date: February 18, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
25414566642700	50	15414566642703		In Commercial Distribution	Dispenser
35414566642707	4	25414566642700		In Commercial Distribution	Case

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 00071483001921 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: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 775-746-6600
Email: jacob.ramirez@ansell.com

Phone: 775-470-7106
Email: don.cronk@ansell.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES