AccessGUDID - DEVICE: Osteotec CBG Guide L (05060183095731)

GUDID

Device Identifier (DI) Information

Brand Name: Osteotec CBG Guide L
Version or Model: OST-CBG-25
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OST-CBG-25
Company Name: OSTEOTEC LIMITED

Primary DI Number: 05060183095731
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 348489386 *Terms of Use

Device Description: To prevent the bones from moving while they are being cut, a jig has been included. K-wires are passed through the jig and are then drilled into each carpal bone. The tube saw can then be passed through the centre and the cut made.

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?
61917	Osteotomy guide, reusable	A surgical instrument intended to be attached to a bone (e.g., pelvis, femur, tibia, ulna) during an osteotomy procedure (including during joint arthroplasty) to outline/define the desired cut-line and mechanically support/guide the cutting device (e.g., oscillating cutting saw). This is a reusable device intended to be sterilized prior to use.	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: 3bdfa606-35c4-49c4-bf74-5b9d12db7fc8
Public Version Date: February 14, 2022
Public Version Number: 1
DI Record Publish Date: February 04, 2022