AccessGUDID - DEVICE: OPERACE (07610733852956)

GUDID

Device Identifier (DI) Information

Brand Name: OPERACE
Version or Model: 80295
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 80295
Company Name: PB SWISS TOOLS AG

Primary DI Number: 07610733852956
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 487856262 *Terms of Use

Device Description: Sterile singel-use trials. Identify the size of the sterile screwdriver insert

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?
64122	Surgical screwdriver trial	A hand-held tool intended to be used to determine the correct size of surgical screwdriver or screwdriver insert required to insert or remove an implantable bone screw. It consists of a set of polymer rods with distal ends in graduated sizes to fit into one of the variations of screw head (e.g., Hex, square, cross-head). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HXB	Probe

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: 1cdf0ba4-b1e0-4050-9214-d7ad9d517708
Public Version Date: October 02, 2024
Public Version Number: 1
DI Record Publish Date: September 24, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +41344377171
Email: info@pbswisstools.com

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