AccessGUDID - DEVICE: OPERACE (07610733850297)

GUDID

Device Identifier (DI) Information

Brand Name: OPERACE
Version or Model: 80029
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 80029
Company Name: PB SWISS TOOLS AG

Primary DI Number: 07610733850297
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 487856262 *Terms of Use

Device Description: Sterile single use insert for the removal of screws with seperated screw head or broken screws

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?
61029	Screw-extraction orthopaedic reamer, single-use	A surgical tool designed for overdrilling, gripping, and extracting an implanted surgical screw shaft when the screw head has become defective or detached, or the shaft has broken. It is in the form of a thin hollow metal shaft, with saw teeth at the cutting edge and a conical thread within the lumen. The device is rotated around the screw shaft to remove a thin layer of bone, either by a surgical power tool or a manual handle, until the internal thread grips the screw for removal. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HTO	Reamer

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: 70555d22-5ed5-4f82-a28a-23e6da3037d4
Public Version Date: October 02, 2024
Public Version Number: 1
DI Record Publish Date: September 24, 2024