AccessGUDID - DEVICE: TissueStat (B532TIS0030)

GUDID

Device Identifier (DI) Information

Brand Name: TissueStat
Version or Model: TIS-003
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: TIS-003
Company Name: Durastat LLC

Primary DI Number: B532TIS0030
Issuing Agency: HIBCC
Commercial Distribution End Date: September 11, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 080315253 *Terms of Use

Device Description: TissueStat (TIS-003) is a class I suture deployment device that allows healthcare professionals to place a needle through soft tissue and facilitates the placement of sutures and knot tying for tissue approximation and/or ligation.

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?
47568	Suturing needle holder, single-use	A hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It has short serrated jaws at the distal end to provide better grip of the needle, and is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HXK	Holder, Needle; Orthopedic

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: 0e0d9c8b-9c0a-4986-9d29-fa1a0fc2403a
Public Version Date: September 30, 2024
Public Version Number: 4
DI Record Publish Date: September 18, 2023