AccessGUDID - DEVICE: TopCare health (00036800542181)

GUDID

Device Identifier (DI) Information

Brand Name: TopCare health
Version or Model: 036800542181
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Topco Associates, LLC

Primary DI Number: 00036800542181
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 60
Labeler D-U-N-S® Number*: 072943876 *Terms of Use

Device Description: Antibacterial, Smart-Flex Bandages, assorted, 1 1/8 IN x 2 5/8 IN (2.8 cm x 6.7 cm); 7/8 IN x 2 3/4 IN (2.2 cm x 6.9 cm); 5/8 IN x 2 1/4 IN (1.5 cm x 5.7 cm)

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?
47378	Skin-cover adhesive strip, antimicrobial	A small, narrow, flexible band (of fabric, plastic, paper, or other material) intended to cover a superficial wound, that is coated on one side with a pressure-sensitive adhesive and that has an absorbent pad prefilled (soaked) with an antiseptic to inhibit the growth of microorganisms. It may also be hypoallergenic and/or waterproof. Commonly referred to as a sticking plaster, it is intended for use in the home or a clinical setting. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGX	Tape And Bandage, Adhesive

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
No Device Sizes

Device Record Status

Public Device Record Key: 65c4714e-801c-44b7-ac26-52b44c661c78
Public Version Date: September 18, 2024
Public Version Number: 2
DI Record Publish Date: October 26, 2020