AccessGUDID - DEVICE: BandGrip® Micro-Anchor® Skin Closure (00850010207070)

GUDID

Device Identifier (DI) Information

Brand Name: BandGrip® Micro-Anchor® Skin Closure
Version or Model: BG1001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: BG1001
Company Name: BANDGRIP INC.

Primary DI Number: 00850010207070
Issuing Agency: GS1
Commercial Distribution End Date: December 15, 2020
Device Count: 36
Labeler D-U-N-S® Number*: 080545512 *Terms of Use

Device Description: 9 cm x 4 cm; w/ 2 Strips

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):	No
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?
32207	Skin-closure adhesive strip	A small, narrow flexible band (of fabric, plastic, paper, or other material) coated on one side with a pressure-sensitive adhesive, used to approximate the edges of superficial wounds. The device may be hypoallergenic and/or waterproof. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FZQ	CLIP, REMOVABLE (SKIN)
GDT	STAPLE, REMOVABLE (SKIN)
KGX	Tape and bandage, adhesive
MKY	SYSTEM, SKIN CLOSURE

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: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 9 cm x 4 cm; w/ 2 Strips
Length: 9 Centimeter
Width: 4 Centimeter

Device Record Status

Public Device Record Key: e05b3450-2371-44a6-b288-67a3ac425d3b
Public Version Date: March 02, 2021
Public Version Number: 2
DI Record Publish Date: March 24, 2020