AccessGUDID - DEVICE: Sterion® Skin Closure (00840113225699)

GUDID

Device Identifier (DI) Information

Brand Name: Sterion® Skin Closure
Version or Model: 751042PCS
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ASPEN SURGICAL PRODUCTS, INC.

Primary DI Number: 00840113225699
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 027680821 *Terms of Use

Device Description: Intended for skin closure and closure support for sutures and staples

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?
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
FPX	Strip, adhesive, closure, skin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K874813	000

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: 32fcda2b-7051-418a-a262-69bce6175f10
Public Version Date: March 05, 2021
Public Version Number: 1
DI Record Publish Date: February 25, 2021