AccessGUDID - DEVICE: Omnia Medical TiBrid™-SC (00843511105020)

GUDID

Device Identifier (DI) Information

Brand Name: Omnia Medical TiBrid™-SC
Version or Model: 10-5C-AWL1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10-5C-AWL1
Company Name: OMNIA MEDICAL, LLC

Primary DI Number: 00843511105020
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079467378 *Terms of Use

Device Description: STRAIGHT AWL

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):	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?
15275	Bone awl, reusable	A spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end, typically made of metallic and/or synthetic material. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K212612	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e0e0f1ae-7bb5-4167-a8a1-7c083741a928
Public Version Date: February 15, 2024
Public Version Number: 1
DI Record Publish Date: February 07, 2024