AccessGUDID - DEVICE: CINCH (00842071119515)

GUDID

Device Identifier (DI) Information

Brand Name: CINCH
Version or Model: TSD-0406
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TSD-0406, TSD-0406-10, TSD-0406-50
Company Name: APPLIED MEDICAL TECHNOLOGY, INC.

Primary DI Number: 00842071119515
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 038101861 *Terms of Use

Device Description: AMT Cinch™ Tube Securement Device

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?
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
PYO	Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use

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: 69c081ef-ff75-46cf-8e58-5cb1d0e775df
Public Version Date: June 10, 2022
Public Version Number: 3
DI Record Publish Date: October 26, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00842071119522	10	00842071119515		In Commercial Distribution	TSD-0406-10 (Box 10)
00842071119539	50	00842071119515		In Commercial Distribution	TSD-0406-50 (Box 50)