AccessGUDID - DEVICE: EVOL®ha-C Cervical Interbody System (00841193120836)

GUDID

Device Identifier (DI) Information

Brand Name: EVOL®ha-C Cervical Interbody System
Version or Model: CES-355
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CES-355
Company Name: Cutting Edge Spine, LLC

Primary DI Number: 00841193120836
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 069472647 *Terms of Use

Device Description: Cervical Inserter With Stop

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?
12696	Orthopaedic inorganic implant inserter/extractor, reusable	A hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. 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: 8 Inch

Device Record Status

Public Device Record Key: 6a67a1aa-713c-4a63-bf59-b5ea99463a14
Public Version Date: September 11, 2024
Public Version Number: 5
DI Record Publish Date: August 15, 2018