AccessGUDID - DEVICE: TSI (00843059116366)

GUDID

Device Identifier (DI) Information

Brand Name: TSI
Version or Model: TK-0408S
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: TEDAN SURGICAL INNOVATIONS, L.L.C.

Primary DI Number: 00843059116366
Issuing Agency: GS1
Commercial Distribution End Date: June 14, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 791619393 *Terms of Use

Device Description: BLUNT SCALP HOOK, LARGE

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?
64022	Soft-tissue surgical hook, single-use	A hand-held, shaft-like, manual surgical instrument designed for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct), to facilitate surgical intervention; it is not dedicated to separating or drawing aside the margins of a surgical wound/incision (i.e., not a blade-style retractor). The device includes a handle and tapers towards the distal end to form a slender hook/parallel hooks. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDG	Hook, Surgical, General & Plastic Surgery

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: 3b20774c-3f17-4846-86c1-be84463efb46
Public Version Date: June 15, 2023
Public Version Number: 3
DI Record Publish Date: November 10, 2017