AccessGUDID - DEVICE: Yellowstone (B587TT15103670)

GUDID

Device Identifier (DI) Information

Brand Name: Yellowstone
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TT151036-7
Company Name: SUMMIT SPINE LLC

Primary DI Number: B587TT15103670
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079539689 *Terms of Use

Device Description: TLIF Sizing Trial 15mm H x 10mm W x 36mm L x 7 degrees

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?
44788	Spinal implant trial	A copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.	Active	false

[?]

FDA Product Code

Product Code	Product Code Name
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar

[?]

FDA Premarket Submission

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

Sterilization

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

Storage and Handling
No storage/handling found

[?]

Clinically Relevant Size

[?]

Size Type Text
Width: 10 Millimeter
Length: 36 Millimeter
Height: 15 Millimeter
Angle: 7 degree

Device Record Status

Alternative and Additional Identifiers Additional Identifiers

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Customer Contact

[?]

DEVICE: Yellowstone (B587TT15103670)

Device Identifier (DI) Information

Device Characteristics

GMDN

FDA Product Code

FDA Premarket Submission

Sterilization

Storage and Handling

Clinically Relevant Size

Device Record Status

Alternative and Additional Identifiers Additional Identifiers

Package DI

Secondary DI

Unit of Use DI

Direct Marking (DM)

Production Identifier(s) in UDI

Customer Contact