AccessGUDID - DEVICE: Osteotec CBG Soft Tissue Displacer Large (05060183095762)

GUDID

Device Identifier (DI) Information

Brand Name: Osteotec CBG Soft Tissue Displacer Large
Version or Model: OST-CBG-22
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OST-CBG-22
Company Name: OSTEOTEC LIMITED

Primary DI Number: 05060183095762
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 348489386 *Terms of Use

Device Description: To minimize soft tissue damage, two different size displacers have been included in the kit. The two parts are slotted together and then pushed through the soft tissue until the bone is reached. The central part of the displacer can then be removed, and the tube saw can be inserted. This will stop the saw teeth from ‘snagging’ on and damaging the soft tissue and thus help reduce the recovery time.

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?
33997	Surgical drill guide obturator	A surgical device designed to fill the lumen of a drill guide during its insertion to a surgical site primarily to prevent tissue obstruction of the drill guide lumen. When the drill guide is firmly placed at the chosen position on the bone surface, the obturator is removed. It is typically a rod with a rounded distal end, which protrudes out of the drill guide, and a knob-like handle that functions as a regulator to control the length of the protruding end and to remove it from the drill guide. It is typically made of a 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: 513de534-7c4b-4fa2-9a91-463de0a527e5
Public Version Date: February 14, 2022
Public Version Number: 1
DI Record Publish Date: February 04, 2022