AccessGUDID - DEVICE: EVOL®ha-C Cervical Interbody System (00841193121239)

GUDID

Device Identifier (DI) Information

Brand Name: EVOL®ha-C Cervical Interbody System
Version or Model: CES-404
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CES-404
Company Name: Cutting Edge Spine, LLC

Primary DI Number: 00841193121239
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 069472647 *Terms of Use

Device Description: EVOL®ha-C Cervical TAMP

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:	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?
32873	Surgical tamp, reusable	A hand-held, surgical instrument designed to be used to manually pack tissue or other material during a surgical intervention. It typically consists of a shaft that terminates in a blunt (flat or profiled) tip at the distal end and a handle at the proximal end. It is typically a one-piece instrument made of metal, however some types may employ a synthetic material for the handle (e.g., Tufnol). The surgeon may pack the material by applying hand pressure to the device or by tapping the proximal end with a hammer/mallet. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ODP	Intervertebral fusion device with bone graft, cervical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180674	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
Special Storage Condition, Specify: Store at room temperature

Clinically Relevant Size

[?]

Size Type Text
Length: 400 Millimeter

Device Record Status

Public Device Record Key: 852cd5af-c469-4ae0-94db-3f5922efdf59
Public Version Date: August 09, 2019
Public Version Number: 2
DI Record Publish Date: August 31, 2018