AccessGUDID - DEVICE: Affirm Prone Biopsy System (15420045506503)

GUDID

Device Identifier (DI) Information

Brand Name: Affirm Prone Biopsy System
Version or Model: PBX-SYS-AFFIRM-2D
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PBX-SYS-AFFIRM-2D
Company Name: Hologic, Inc.

Primary DI Number: 15420045506503
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 139534114 *Terms of Use

Device Description: AFFIRM PRONE BIOPSY SYSTEM, 2D

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 [?]
K153486	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 -10 and 40 Degrees Celsius
Storage Environment Humidity: between 0 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 892c7ffe-74a5-4cb0-8bd4-bb215b6383d0
Public Version Date: April 19, 2024
Public Version Number: 4
DI Record Publish Date: April 26, 2017