AccessGUDID - DEVICE: Sound Body (00481042591105)

GUDID

Device Identifier (DI) Information

Brand Name: Sound Body
Version or Model: 481042591105
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Aso LLC

Primary DI Number: 00481042591105
Issuing Agency: GS1
Commercial Distribution End Date: October 31, 2023
Device Count: 20
Labeler D-U-N-S® Number*: 152793493 *Terms of Use

Device Description: Waterproof Adhesive Bandages, assorted sizes, 3/4 IN x 1 1/2 IN (19 mm x 38 mm); 3/4 IN x 2 IN (19 mm x 50 mm); 1 IN x 2 1/2 IN (25 mm x 63 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":	Yes
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?
44990	Skin-cover adhesive strip, non-antimicrobial	A small, narrow, flexible band (of fabric, plastic, paper, or other material) coated on one side with a pressure-sensitive adhesive and possibly with an absorbent pad, typically intended to cover a superficial wound or fix a dressing to skin. It may be hypoallergenic and/or waterproof, however it does not include antimicrobial agents/properties. Commonly referred to as a sticking plaster, 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
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: Yes
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: 55a5cf2a-5570-488c-9a02-37d4f203d739
Public Version Date: October 31, 2023
Public Version Number: 3
DI Record Publish Date: September 27, 2020