AccessGUDID - DEVICE: NA (04546540142429)

GUDID

Brand Name: NA
Version or Model: 01-17840
Catalog Number: 01-17840
Company Name: Stryker Leibinger GmbH & Co. KG

Primary DI Number: 04546540142429
Issuing Agency: GS1
Device Count: 1

Device Description: INTERDENTAL OSTEOTOME, OBWEGESER

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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Orthopaedic surgical procedure kit, non-medicated, reusable	A collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Product Code	Product Code Name
LRC	INSTRUMENT, ENT MANUAL SURGICAL

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling
No storage/handling found

Size Type Text
Width: 3.0 Millimeter
Length: 15.5 Centimeter

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: December 08, 2016
Commercial Distribution End Date:

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

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

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

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

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

No Customer Contact currently defined