AccessGUDID - DEVICE: Pristina Serena (00195278347596)

GUDID

Device Identifier (DI) Information

Brand Name: Pristina Serena
Version or Model: KAS2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GE MEDICAL SYSTEMS

Primary DI Number: 00195278347596
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 266062561 *Terms of Use

Device Description: Biopsy Option

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):	No
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?
36513	Mammographic x-ray system stereotactic unit	A device that can only fulfil its purpose when used together with and enhance the function of a diagnostic mammographic x-ray system. It is used to take two pictures of a breast from two different angles. On the basis of this stereoscopic picture set, it is possible to determine the exact position of a lesion in the breast and a cytological sample of this will be taken. This device or technique may be built-in to some diagnostic x-ray systems for mammography.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MUE	Full field digital, system, x-ray, mammographic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K173576	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 70 and 106 KiloPascal
Handling Environment Humidity: between 10 and 80 Percent (%) Relative Humidity
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -40 and 70 Degrees Celsius
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6375225d-1ea6-4da4-b2ce-dd850ce6731d
Public Version Date: October 25, 2022
Public Version Number: 2
DI Record Publish Date: April 26, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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