AccessGUDID - DEVICE: PreciseCore (07613252722328)

GUDID

Device Identifier (DI) Information

Brand Name: PreciseCore
Version or Model: 0901810000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0901810000
Company Name: STRYKER CORPORATION

Primary DI Number: 07613252722328
Issuing Agency: GS1
Commercial Distribution End Date: January 05, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 196548481 *Terms of Use

Device Description: Biopsy Device

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 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.

FDA Product Code

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Product Code	Product Code Name
KNW	INSTRUMENT, BIOPSY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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
Device Size Text, specify: Distal Length: 10.0 Centimeter
Device Size Text, specify: Neck Length: 10.0 Millimeter
Needle Gauge: 18.0 Gauge

Device Record Status

Public Device Record Key: dcf26eac-ac18-4fde-86da-7e3082baf822
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016