AccessGUDID - DEVICE: 2.7x8.0mm [2] & 2.7x10.0mm [5] Screws (M9575001120)

GUDID

Device Identifier (DI) Information

Brand Name: 2.7x8.0mm [2] & 2.7x10.0mm [5] Screws
Version or Model: 500112
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Nexus Cmf, L.L.C.

Primary DI Number: M9575001120
Issuing Agency: HIBCC
Commercial Distribution End Date: May 31, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 965540227 *Terms of Use

Device Description: 2.7x8.0mm [2] & 2.7x10.0mm [5] Screws

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?
46638	Craniofacial bone screw, non-bioabsorbable	A small, threaded rod with a slotted and/or polygonal (e.g., hexagonal) head intended to be implanted in craniofacial bone (including the maxilla and/or mandible) for fracture fixation by direct interfragmentary stabilization of bone or by screwing plates in place; it may also be intended for transplanted bone fixation. It may be self-drilling/self-tapping and is made of a material that is not chemically degraded or absorbed via natural body processes [e.g., implant grade metal such as titanium (Ti)]. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, craniotomy flap fixation, bone augmentation procedures.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MPI	Glenoid Fossa Prosthesis
LZD	Joint, Temporomandibular, Implant

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: e62f40f8-89c1-4c39-9fb2-81a2be30fee2
Public Version Date: June 19, 2024
Public Version Number: 7
DI Record Publish Date: September 02, 2016