AccessGUDID - DEVICE: Biotronix Healthcare Cotton Cast Padding (00858835007868)

GUDID

Device Identifier (DI) Information

Brand Name: Biotronix Healthcare Cotton Cast Padding
Version or Model: PO2001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PO2001
Company Name: BIOTRONIX HEALTHCARE INDUSTRIES, INC.

Primary DI Number: 00858835007868
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 065762392 *Terms of Use

Device Description: Cotton Cast Padding, 2" x 4.1yds, 24 Rolls/Bag

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):	Yes
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?
59049	General-purpose medical fibre padding	A roll, sheet or preformed shape of synthetic (e.g., polyester, polypropylene) or natural (e.g., cotton) fibre intended to be applied to and/or compress a local area of the body for various preventative/therapeutic applications (e.g., in compression bandaging, padding under casts and splints, padding for anatomical depressions), typically over intact and healthy skin. 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
ITG	Bandage, Cast

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
Device Size Text, specify: Cotton Cast Padding, 2" x 4.1yds, 24 Rolls/Bag

Device Record Status

Public Device Record Key: 120176b1-7000-4225-972f-4b3b0d752e65
Public Version Date: July 07, 2020
Public Version Number: 3
DI Record Publish Date: October 22, 2019