AccessGUDID - DEVICE: BIOPSY DIGIT (08033837190219)

GUDID

Device Identifier (DI) Information

Brand Name: BIOPSY DIGIT
Version or Model: BIOPSY DIGIT AM
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9100-01
Company Name: I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL

Primary DI Number: 08033837190219
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 429113525 *Terms of Use

Device Description: Biopsy Digit device uses two stereo images taken by a digital solid state camera to determine the location of a lesion in three dimensions. It is intended to mammographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement.

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:	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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36190	Mammographic stereotactic biopsy system	An assembly of devices intended to be used in conjunction with mammography to insert biopsy devices, typically designated needles, into a breast in order to extract a biopsy of a suspect tumour for diagnostic purposes. It consists of a biopsy unit with needle guides, needles, an examination table, and an integral computer for communicating lesion coordinates. This GMDN code includes stand-alone units as well as units that mount onto an existing mammographic radiographic unit.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IZH	System, X-Ray, Mammographic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K990192	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -20 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Height: 347 Millimeter
Depth: 303 Millimeter
Width: 350 Millimeter

Device Record Status

Public Device Record Key: 6dd542fb-d069-42ff-9a28-323e1eedea65
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 22, 2016