AccessGUDID - DEVICE: EMERGE Anterior Cervical Plate System (00195860023112)

GUDID

Device Identifier (DI) Information

Brand Name: EMERGE Anterior Cervical Plate System
Version or Model: 100-A068
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 100-A068
Company Name: Evolution Spine LLC

Primary DI Number: 00195860023112
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 116940934 *Terms of Use

Device Description: Cervical Temp Pin Threaded Large

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):	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?
66938	Spinal intraoperative positioning screw	A nonimplantable threaded rod with a screw head and a drive intended to be temporarily screwed into vertebral bone to assist with the positioning of an implantable device (typically a fixation plate) during spinal surgery. The drive may be one of a variety of designs (e.g., a slot, or of cross, star, or polygonal shape) for use with an appropriate screwdriver. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	Orthopedic manual surgical instrument

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: 01deb3ad-5941-4141-b492-4265166919cf
Public Version Date: May 24, 2024
Public Version Number: 2
DI Record Publish Date: August 21, 2023