AccessGUDID - DEVICE: Blustone Synergy Lumbar TLIF Inserter/Pusher (Obsidian) (00810482031382)

GUDID

Device Identifier (DI) Information

Brand Name: Blustone Synergy Lumbar TLIF Inserter/Pusher (Obsidian)
Version or Model: 9100-TI01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BLUSTONE SYNERGY, LLC

Primary DI Number: 00810482031382
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 033467608 *Terms of Use

Device Description: The BluStone Synergy Obsidian System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899. The Obsidian TLIF implant inserter/pusher is designed to allow for disassembly during cleaning and sterilization. Instructions regarding disassembly, cleaning and sterilization of the inserter/pusher instrument are provided in the product insert.

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?
12696	Orthopaedic inorganic implant inserter/extractor, reusable	A hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FZX	Guide, Surgical, Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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: 45° X .05 Chamfer
Lumen/Inner Diameter: 0.218 Inch

Device Record Status

Public Device Record Key: c3213c5f-e825-4600-8c0e-96a9d96b3829
Public Version Date: September 11, 2024
Public Version Number: 6
DI Record Publish Date: January 29, 2018