AccessGUDID - DEVICE: SofTIP (M95560020)

GUDID

Device Identifier (DI) Information

Brand Name: SofTIP
Version or Model: Long
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6002
Company Name: SENTREHEART, INC

Primary DI Number: M95560020
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 068810802 *Terms of Use

Device Description: A sterile tube-like device intended to facilitate the use of an open-surgery ligature loop ligator by guiding and protecting its passage through other tissues. It is made of plastic materials. This is a single-use 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":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
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?
62315	Open-surgery ligator guide sheath	A sterile tube-like device intended to facilitate the use of an open-surgery ligature loop ligator by guiding and protecting its passage through other tissues. It is made of plastic materials. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K090385	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
Length: 22.5 Centimeter

Device Record Status

Public Device Record Key: cd335f02-2e88-4e5c-b908-f85cc16750c7
Public Version Date: October 18, 2018
Public Version Number: 1
DI Record Publish Date: September 17, 2018