AccessGUDID - DEVICE: 3M™ Steri-Strip™ (00707387804701)

GUDID

Device Identifier (DI) Information

Brand Name: 3M™ Steri-Strip™
Version or Model: R1548
Commercial Distribution Status: In Commercial Distribution
Catalog Number: R1548
Company Name: 3M COMPANY

Primary DI Number: 00707387804701
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 830016148 *Terms of Use

Device Description: 3M™ Steri-Strip™ Reinforced Adhesive Skin Closures, R1548, 1 in x 5 in (25 mm x 125 mm), 4 Strips/Envelope

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):	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?
32207	Skin-closure adhesive strip	A small, narrow flexible band (of fabric, plastic, paper, or other material) coated on one side with a pressure-sensitive adhesive, used to approximate the edges of superficial wounds. The device may be hypoallergenic and/or waterproof. 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: f5594420-4ca6-4128-aba3-250093b2c569
Public Version Date: March 16, 2021
Public Version Number: 1
DI Record Publish Date: March 08, 2021