AccessGUDID - DEVICE: EVOL®SI Joint Fusion System (00841193122625)

GUDID

Device Identifier (DI) Information

Brand Name: EVOL®SI Joint Fusion System
Version or Model: CES-345
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CES-345
Company Name: Cutting Edge Spine, LLC

Primary DI Number: 00841193122625
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 069472647 *Terms of Use

Device Description: EVOL®SI, Radiolucent Wire Clamp

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):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
46453	External orthopaedic fixation system reprocessed component	A component of an external fixation system intended to be used to stabilize a fractured bone/joint. It may be a specially designed frame, clamp, rod, pin, rod-to-rod coupling, rod-to-pin coupling, post, fastener, wire, bolt, washer, nut, hinge, ring, socket, bar, screw, or other device. This is a single-use device that has previously been used on a patient and has been subjected to additional processing and manufacturing for an additional single-use patient application.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

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
Special Storage Condition, Specify: Store at room temperature

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bba75ec3-a02e-415a-a5f1-3fbd8b7678f3
Public Version Date: August 26, 2019
Public Version Number: 1
DI Record Publish Date: August 16, 2019