AccessGUDID - DEVICE: EVOL®ha-C Cervical Interbody System (00841193121222)

GUDID

Device Identifier (DI) Information

Brand Name: EVOL®ha-C Cervical Interbody System
Version or Model: CES-394
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CES-394
Company Name: Cutting Edge Spine, LLC

Primary DI Number: 00841193121222
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 MALLET

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?
32312	Surgical mallet	A hand-held manual surgical instrument designed to strike a surface or another device (e.g., a surgical chisel, gouge, driver) to drive it during a surgical intervention. It is available in a variety of designs and materials; the shaft is typically made of metal (e.g., chromed iron (Fe) or high-grade stainless steel), but can be made of synthetic materials (e.g., Tufnol), and tapers distally to the head. The head is typically a solid, cylindrical shape normally being double-ended and made of solid (iron/steel) or shock-absorbing materials (e.g., rubber, plastic, or Tufnol). Also referred to as a surgical hammer it may also be used for autopsy. 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: 600 Millimeter

Device Record Status

Public Device Record Key: fe49d568-07cb-44cb-aa93-c910194895a3
Public Version Date: October 01, 2018
Public Version Number: 1
DI Record Publish Date: August 31, 2018