AccessGUDID - DEVICE: PreciseCore (07613252722328)

GUDID

Brand Name: PreciseCore
Version or Model: 0901810000
Catalog Number: 0901810000
Company Name: STRYKER CORPORATION

Primary DI Number: 07613252722328
Issuing Agency: GS1
Device Count: 1

Device Description: Biopsy Device

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

GMDN Preferred Term Name	GMDN Definition
Silicone dental impression material	An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.

Product Code	Product Code Name
KNW	INSTRUMENT, BIOPSY

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling
No storage/handling found

Size Type Text
Device Size Text, specify: Distal Length: 10.0 Centimeter
Device Size Text, specify: Neck Length: 10.0 Millimeter
Needle Gauge: 18.0 Gauge

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: September 23, 2016
Commercial Distribution End Date:

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
37613252722329	5	07613252722328		In Commercial Distribution	pack

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: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Phone: +1(800)253-3210
Email: Inst.Stryker.cs@Stryker.com