AccessGUDID - DEVICE: ATEC Sapphire 200 (15420045504110)

GUDID

Device Identifier (DI) Information

Brand Name: ATEC Sapphire 200
Version or Model: ATEC Sapphire 200
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ATEC SAPPHIRE 200
Company Name: Hologic, Inc.

Primary DI Number: 15420045504110
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 153623137 *Terms of Use

Device Description: 200 ALL IN ONE BREAST BIOPSY SYSTEM FOR BIOPSIES UNDER STEREOTACTIC, ULTRASOUND OR MRI GUIDANCE

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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
KNW	INSTRUMENT, BIOPSY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K042290	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
Handling Environment Atmospheric Pressure: between 812 and 1014 millibar
Handling Environment Temperature: between 15 and 40 Degrees Celsius
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Storage Environment Temperature: between -29 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dade5649-772e-4200-9fe8-9b57d8e9064c
Public Version Date: February 24, 2025
Public Version Number: 6
DI Record Publish Date: August 17, 2015