AccessGUDID - DEVICE: NA (10705034719887)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 03.632.395
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 03632395
Company Name: Synthes GmbH

Primary DI Number: 10705034719887
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 486711679 *Terms of Use

Device Description: 12MM UNIVERSAL NAVIGATION INTERFACE

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?
47847	Orthopaedic implant-instrument extension adaptor, reusable	A connecting device designed to join an orthopaedic implant to a surgical instrument, or a surgical instrument to another instrument, typically to create an extension for removal of the implant (e.g., during a percutaneous interspinous distraction procedure for the removal of a distraction sleeve), or to connect two devices with incompatible interfaces. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of sizes and lengths. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OLO	Orthopedic stereotaxic instrument
HAW	Neurological stereotaxic Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K122211	000

Device Exempt from Premarket Submission: No 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: 25e90381-c262-4f82-908d-275f5d75fb92
Public Version Date: May 03, 2023
Public Version Number: 5
DI Record Publish Date: June 30, 2016

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
HIBCC	H981036323950

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: Yes
DM DI Number: 07611819588912
CLOSE

Production Identifier(s) in UDI

[?]

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

Customer Contact

[?]

Phone: +1(800)255-2500
Email: xx@xx.xx

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