AccessGUDID - DEVICE: Assured (00639277232540)

GUDID

Device Identifier (DI) Information

Brand Name: Assured
Version or Model: 234391
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Dollar Tree Mdsg Chesapeake Ci

Primary DI Number: 00639277232540
Issuing Agency: GS1
Commercial Distribution End Date: August 31, 2021
Device Count: 80
Labeler D-U-N-S® Number*: 610322518 *Terms of Use

Device Description: Sheer Bandages, assorted sizes, 3/4 in 3 in (1.9 cm x 7.6 cm); 3/4 in x 1 1/2 in (1.9 cm x 3.8 cm); 1/3 in x 1 1/2 in (0.8 cm x 3.8 cm)

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?
16866	Dressing-fixation skin adhesive tape, non-silicone	A long and narrow flexible band of non-silicone-based material (e.g., fabric, plastic, paper) coated on one or both sides with a pressure-sensitive adhesive, intended to non-invasively adhere to the skin surface to fix a dressing in place or attach objects (e.g., catheter, lamp); it might have hypoallergenic and/or waterproof properties. 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: 1122c6ea-dfa4-436f-8b23-cf3350943de5
Public Version Date: June 10, 2022
Public Version Number: 3
DI Record Publish Date: May 29, 2020