AccessGUDID - DEVICE: Streamline TL Spinal Fixation System (00191083024660)

GUDID

Device Identifier (DI) Information

Brand Name: Streamline TL Spinal Fixation System
Version or Model: 10-55-PR-35
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 10-55-PR-35
Company Name: Rti Surgical, Inc.

Primary DI Number: 00191083024660
Issuing Agency: GS1
Commercial Distribution End Date: January 17, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 117560455 *Terms of Use
Previous DI: 00846468001117

Device Description: ROD, PRE-BENT

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
67309	Bone-screw internal spinal fixation system sterilization container/implant set	A collection of non-sterile, implantable components of a bone-screw internal spinal fixation system (e.g., rods, screws, connectors, hooks) supplied within a reusable sterilization container (i.e., all under the same product code) to be sterilized before they are implanted as part of an internal spinal fixation procedure. The set provides the surgeon with a selection of implants (e.g., different sizes) during surgery, whereby unused implants maybe resterilised for subsequent implantation in another patient. This is a reusable device which includes single-use implants.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KWP	APPLIANCE, FIXATION, SPINAL INTERLAMINAL
NKB	Thoracolumbosacral pedicle screw system

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
No Device Sizes

Device Record Status

Public Device Record Key: dd756a35-1ecc-483c-b05c-1917a011ff5c
Public Version Date: July 02, 2025
Public Version Number: 7
DI Record Publish Date: June 25, 2021