AccessGUDID - DEVICE: TopCare health (00036800259775)

GUDID

Device Identifier (DI) Information

Brand Name: TopCare health
Version or Model: 036800259775
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Topco Associates, LLC

Primary DI Number: 00036800259775
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 072943876 *Terms of Use

Device Description: Hydrocolloid Blister Cushions, toes and heels, 1.65 IN x 2.67 IN (42 mm x 68 mm); 1.33 IN x 2.12 IN (34 mm x 54 mm); 0.66 IN x 2.32 IN (17 mm x 59 mm)

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):	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?
62873	Exudate-absorbent dressing, hydrophilic-gel, non-sterile	A non-sterile adhesive covering intended to assist treatment and protection of fluid-filled superficial lesions (e.g., cold sores, mild acne spots/pimples, opened blisters) and/or minor abrasions by producing a water-absorbent gel upon contact with exudate and maintaining a moist environment; it does not contain an antimicrobial agent. It may be available in various forms (e.g., flat sheet/film, pad) and is typically made of hydrocolloid. It is normally available [non-prescription] over-the-counter (OTC). After application, this device cannot be reused.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
NAD	Dressing, Wound, Occlusive

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
No Device Sizes

Device Record Status

Public Device Record Key: 20464f26-2eeb-4c78-aff8-0b1cc682d1dd
Public Version Date: September 18, 2024
Public Version Number: 2
DI Record Publish Date: July 13, 2020