AccessGUDID - DEVICE: ShurFit Lumbar Interbody (00840019947732)

GUDID

Device Identifier (DI) Information

Brand Name: ShurFit Lumbar Interbody
Version or Model: 72-CPA-2414
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 72-CPA-2414
Company Name: PRECISION SPINE, INC.

Primary DI Number: 00840019947732
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079398589 *Terms of Use

Device Description: 24 x 14mm 0° Curved PEEK Interbody

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":	Yes
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?
60676	JAK2 V617F gene mutation IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used to detect or monitor the V617F mutation in the Janus kinase 2 (JAK2) gene in a clinical specimen. This mutation is associated with haematological abnormalities that may include essential thrombocythemia, polycythemia vera, primary myelofibrosis or leukaemia.	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 [?]
K212075	000

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: 512a6b5b-ea54-4d07-8f19-5eac16f6f680
Public Version Date: October 27, 2022
Public Version Number: 1
DI Record Publish Date: October 19, 2022