AccessGUDID - DEVICE: ENCOR® (00801741086489)

GUDID

Device Identifier (DI) Information

Brand Name: ENCOR®
Version or Model: ENCFINSERT7G
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ENCFINSERT7G
Company Name: SENORX, INC.

Primary DI Number: 00801741086489
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 043674543 *Terms of Use

Device Description: ENCOR® Breast Biopsy System Needle Guide Insert (GE™/Siemens™/Fischer™/Giotto™), 7G

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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
16835	Soft-tissue biopsy procedure kit, non-medicated	A collection of sterile devices designed to perform a non-specific soft tissue biopsy. It includes the biopsy needle used for this procedure; it does not include a pharmaceutical. This is a single-use device.	Active	false

FDA Product Code

[?]

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: 7, Gauge

Device Record Status

Public Device Record Key: a9a6d248-2db3-46f7-b622-3f85cc412204
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 20, 2016