AccessGUDID - DEVICE: Reform Midline Cortical Screw System (00840019927727)

GUDID

Device Identifier (DI) Information

Brand Name: Reform Midline Cortical Screw System
Version or Model: 59-RD-0051
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 59-RD-0051
Company Name: PRECISION SPINE, INC.

Primary DI Number: 00840019927727
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079398589 *Terms of Use

Device Description: In Situ Bender, Right

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:	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?
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
HXW	Bender

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: 25fc38dc-37f9-4358-874e-db5b7d5bc479
Public Version Date: May 17, 2019
Public Version Number: 1
DI Record Publish Date: May 09, 2019