AccessGUDID - DEVICE: Streamline TL Spinal Fixation System (00846468001643)

GUDID

Device Identifier (DI) Information

Brand Name: Streamline TL Spinal Fixation System
Version or Model: 10-RTHANDLE
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 10-RTHANDLE
Company Name: Xtant Medical Holdings, Inc.

Primary DI Number: 00846468001643
Issuing Agency: GS1
Commercial Distribution End Date: May 26, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 081224143 *Terms of Use
Previous DI: 00846468021795

Device Description: T-HANDLE, RATCHETING

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?
47829	Surgical instrument handle, non-torque-limiting	A hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

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: 02737582-f4dd-4fd6-9638-eb2e1a9efc70
Public Version Date: April 08, 2025
Public Version Number: 5
DI Record Publish Date: May 05, 2021