AccessGUDID - DEVICE: Ti6® Internal Fixation System (10381780245063)

GUDID

Device Identifier (DI) Information

Brand Name: Ti6® Internal Fixation System
Version or Model: FS2070
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FS2070
Company Name: Ascension Orthopedics, Inc.

Primary DI Number: 10381780245063
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 942377524 *Terms of Use

Device Description: Integra® Ti6® The Ti6 CounterSink is used to add space or clearance for the head of a TS-Series 2.0 or 2.5mm screw.

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?
33968	Surgical screwdriver, reusable	A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HXX	SCREWDRIVER

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
Device Size Text, specify: Small; 3.75 in L

Device Record Status

Public Device Record Key: 70709781-cc32-483f-9d0e-4242dff48fff
Public Version Date: January 25, 2023
Public Version Number: 5
DI Record Publish Date: September 05, 2017