AccessGUDID - DEVICE: Medicom AssureTouch (10686864060045)

GUDID

Device Identifier (DI) Information

Brand Name: Medicom AssureTouch
Version or Model: 1147-7
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1147-7
Company Name: AMD Medicom Inc

Primary DI Number: 10686864060045
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 256880576 *Terms of Use

Device Description: Medicom AssureTouch React - Polyisoprene Surgical Gloves - Powder Free - Sterile - Natural White - Size 7

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 [?]
K112654	000

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
Special Storage Condition, Specify: Store in a cool dry place. Avoid excessive heat (40°C, 104°F)

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 7

Device Record Status

Public Device Record Key: 7b84f2d4-3a68-482f-ba26-568f210177b4
Public Version Date: March 13, 2024
Public Version Number: 1
DI Record Publish Date: March 05, 2024