AccessGUDID - DEVICE: Reform Pedicle Screw System (00840019937351)

GUDID

Device Identifier (DI) Information

Brand Name: Reform Pedicle Screw System
Version or Model: 39-BK-0202
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 39-BK-0202
Company Name: PRECISION SPINE, INC.

Primary DI Number: 00840019937351
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079398589 *Terms of Use

Device Description: Instrument Kit 2

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?
64192	Internal spinal fixation procedure kit, reusable	A collection of various orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure (including stereotactic procedures); implanted devices are not included. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MNH	Orthosis, Spondylolisthesis Spinal Fixation
MNI	Orthosis, Spinal Pedicle 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: 1ef7ef2a-d239-4c49-b433-7da6682a1f0b
Public Version Date: July 31, 2024
Public Version Number: 2
DI Record Publish Date: September 04, 2019