AccessGUDID - DEVICE: T-Handle Chuck (10855068008232)

GUDID

Device Identifier (DI) Information

Brand Name: T-Handle Chuck
Version or Model: SGC-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SGC-001
Company Name: Curvafix Inc

Primary DI Number: 10855068008232
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 039779098 *Terms of Use

Device Description: A hand-held manual surgical instrument designed to drive the CurvaFix Steerable Guide into the intramedullary space.

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:	No
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?
35436	Manual wire driver	A hand-held manual surgical instrument (drill-like) designed to drive orthopaedic bone wires, e.g., Steinmann pins, Kirschner wires or K-Wires (thin needle-like pins of different thickness that are pointed for self-drilling) into fractured/deformed bones for their restoration. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LHX	Trousers, Anti-Shock

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 303e8e77-66bd-44b0-adfb-380edef5c451
Public Version Date: August 01, 2023
Public Version Number: 2
DI Record Publish Date: August 11, 2021