AccessGUDID - DEVICE: LOL Surprise Antibacterial Bandages (00017276235302)

GUDID

Device Identifier (DI) Information

Brand Name: LOL Surprise Antibacterial Bandages
Version or Model: 017276235302
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Aso LLC

Primary DI Number: 00017276235302
Issuing Agency: GS1
Commercial Distribution End Date: September 07, 2023
Device Count: 20
Labeler D-U-N-S® Number*: 152793493 *Terms of Use

Device Description: LOL Surprise Antibacterial Bandages, assorted shapes and sizes, 3/4 STRIPS .75 IN x 3 IN (19 mm x 76 mm); CIRCLE 1.45 IN x 1.45 IN (36 mm x 36 mm); HEART 1.64 IN x 1.39 IN (41 mm x 35 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: 28769a7b-275d-450c-87af-2af470c6295d
Public Version Date: September 22, 2023
Public Version Number: 5
DI Record Publish Date: February 28, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20017276235962	24	00017276235968	2023-09-07	Not in Commercial Distribution	case
00017276235968	5	00017276235302	2023-09-07	Not in Commercial Distribution	box
20017276236051	24	00017276236057	2023-01-31	Not in Commercial Distribution	case
00017276236057	5	00017276235302	2023-01-31	Not in Commercial Distribution	box
20017276235306	72	00017276235302	2023-09-07	Not in Commercial Distribution	case
10017276235309	24	00017276235302	2023-09-07	Not in Commercial Distribution	case
00017276236958	3	00017276235302	2023-03-09	Not in Commercial Distribution	box
20017276236952	72	00017276236958	2023-03-09	Not in Commercial Distribution	case