AccessGUDID - DEVICE: Reform Pedicle Screw System (00840019929080)

GUDID

Device Identifier (DI) Information

Brand Name: Reform Pedicle Screw System
Version or Model: 39-SC-0500
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 39-SC-0500
Company Name: PRECISION SPINE, INC.

Primary DI Number: 00840019929080
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079398589 *Terms of Use

Device Description: Reform® Modular Pedicle Screw Implant Case

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?
44054	Orthopaedic surgical procedure kit, non-medicated, reusable	A collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MNI	Orthosis, Spinal Pedicle Fixation
MNH	Orthosis, Spondylolisthesis Spinal Fixation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121172	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: 7184e72b-4f07-417a-aebb-ea325d8695e4
Public Version Date: June 07, 2019
Public Version Number: 1
DI Record Publish Date: May 30, 2019