AccessGUDID - DEVICE: NA (04546540356628)

GUDID

Brand Name: NA
Version or Model: 62-00302
Catalog Number: 62-00302
Company Name: Stryker Leibinger GmbH & Co. KG

Primary DI Number: 04546540356628
Issuing Agency: GS1
Device Count: 1

Device Description: CHEEK RETRACTOR FOR 62-00301, FIXED

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
Basic dental retractor	A hand-held dental instrument intended to be used to manually displace soft tissues of the oral cavity to improve their visualization and access and to afford them protection during oral surgical procedures. It is made of high-grade stainless steel. This is a reusable device.

Product Code	Product Code Name
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

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

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