AccessGUDID - DEVICE: VACSURE Uni-Band (00850014448134)

GUDID

Device Identifier (DI) Information

Brand Name: VACSURE Uni-Band
Version or Model: RR-151
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LABOTEK GROUP CORP

Primary DI Number: 00850014448134
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 117338398 *Terms of Use

Device Description: VACSURE Uni-Band, Universal bandage, 28 x 15 mm pad size, 19 x 38 mm overall size, Individually wrapped

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?
34864	Adhesive bandage	A sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). 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: 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: 28 Millimeter
Width: 15 Millimeter

Device Record Status

Public Device Record Key: 85584b7f-4f7a-463f-a1b1-605ffe10d548
Public Version Date: March 26, 2024
Public Version Number: 1
DI Record Publish Date: March 18, 2024