AccessGUDID - DEVICE: Avitus Pilot Hole Creator, Disposable

GUDID

Device Identifier (DI) Information

Brand Name: Avitus Pilot Hole Creator, Disposable - 8mm
Version or Model: PC-200
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PC-200
Company Name: AVITUS ORTHOPAEDICS, INC.

Primary DI Number: 00857373006012
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078269403 *Terms of Use

Device Description: Disposable surgical instrument with 8mm tip for manually cutting a hole into bone allowing access to cancellous bone.

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?
66274	Bone awl, single-use	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 single-use 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: 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: aca71042-ba41-4c28-a402-50d953465d24
Public Version Date: May 30, 2025
Public Version Number: 2
DI Record Publish Date: December 08, 2022