AccessGUDID - DEVICE: Osteotec CBG Tube Saw S

GUDID

Device Identifier (DI) Information

Brand Name: Osteotec CBG Tube Saw S - size 3
Version or Model: OST-CBG-03
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OST-CBG-03
Company Name: OSTEOTEC LIMITED

Primary DI Number: 05060183095618
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 348489386 *Terms of Use

Device Description: The 8 tube saws, ranging from 6.5mm Outside Diameter to 17mm Outside Diameter, are sized so that the inside diameter of the larger saw will cut a dowel that will compression fit into the hole formed by the outer diameter of the next size down. The saws and the accompanying instrumentation will allow accurate removal of damaged arthritic bone and insertion of a healthy bone dowel to encourage fusion.

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?
14147	Bone trephine, reusable	An orthopaedic surgical blade designed to cut and remove circular sections of bone, typically for biopsy or percutaneous bone graft harvesting. It is typically a hollow cylinder with a circular, saw-like serrated working edge. It is an exchangeable device that may be attached to a manually-operated handle or to a powered rotary surgical handpiece. The device is typically made of high-grade stainless steel. 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: 21408648-b4d5-4803-a645-23f442de5c9c
Public Version Date: April 03, 2024
Public Version Number: 2
DI Record Publish Date: February 04, 2022