AccessGUDID - DEVICE: Jojo Siwa Antibacterial Bandages (00017276234879)

GUDID

Device Identifier (DI) Information

Brand Name: Jojo Siwa Antibacterial Bandages
Version or Model: 017276234879
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Aso LLC

Primary DI Number: 00017276234879
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 152793493 *Terms of Use

Device Description: Jojo Siwa Antibacterial Bandages, assorted shapes and sizes, 3/4 STRIPS .75 IN x 3 IN (19 mm x 76 mm); HEART 1.64 IN x 1.39 IN (41 mm x 35 mm); BOW 2 IN x 1.5 IN (51 mm x 38 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?
47378	Skin-cover adhesive strip, antimicrobial	A small, narrow, flexible band (of fabric, plastic, paper, or other material) intended to cover a superficial wound, that is coated on one side with a pressure-sensitive adhesive and that has an absorbent pad prefilled (soaked) with an antiseptic to inhibit the growth of microorganisms. It may also be hypoallergenic and/or waterproof. 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: No 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: 652f242d-d483-4ca2-a6f5-3091969dc69f
Public Version Date: August 04, 2022
Public Version Number: 5
DI Record Publish Date: December 30, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20017276236044	24	00017276236040		In Commercial Distribution	case
00017276236040	5	00017276234879		In Commercial Distribution	box
20017276234873	72	00017276234879		In Commercial Distribution	case
10017276234876	24	00017276234879		In Commercial Distribution	case
00017276236965	3	00017276234879	2022-05-03	Not in Commercial Distribution	box
20017276236969	72	00017276236965	2022-05-03	Not in Commercial Distribution	case