AccessGUDID - DEVICE: Dynamic Tissue Systems™ (10620974001802)

GUDID

Device Identifier (DI) Information

Brand Name: Dynamic Tissue Systems™
Version or Model: CWM02A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CWM02A
Company Name: Southmedic Incorporated

Primary DI Number: 10620974001802
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 246848147 *Terms of Use

Device Description: ABRA® Adhesive Skin Closure Set

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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
LRO	General surgery tray

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
Device Size Text, specify: ABRA® Adhesive Skin Closure Set

Device Record Status

Public Device Record Key: 0b42f56b-eaa6-4985-9216-56a45533e5c5
Public Version Date: December 13, 2018
Public Version Number: 1
DI Record Publish Date: November 12, 2018