AccessGUDID - DEVICE: DARCO® Body Armor® Elastic Tape (black) (00609271619951)

GUDID

Device Identifier (DI) Information

Brand Name: DARCO® Body Armor® Elastic Tape (black)
Version or Model: BAET-B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BAET-B
Company Name: DARCO INTERNATIONAL, INC.

Primary DI Number: 00609271619951
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 184231298 *Terms of Use

Device Description: No description.

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):	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?
66337	Limb immobilization/support skin adhesive tape	A flexible band of fabric, plastic, or other material intended to noninvasively adhere to the skin surface to immobilize a joint and/or support a limb. It may be referred to as sports tape, functional tape, or kinesiology tape and is coated on one side with a pressure-sensitive adhesive and designed with a lower potential for producing an allergic reaction (i.e., hypoallergenic). 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
No Device Sizes

Device Record Status

Public Device Record Key: ad21b6b6-d60e-4593-895d-b8ae3739291e
Public Version Date: February 16, 2023
Public Version Number: 1
DI Record Publish Date: February 08, 2023