AccessGUDID - DEVICE: Atellica IM cPSA PRE (00630414598703)

GUDID

Device Identifier (DI) Information

Brand Name: Atellica IM cPSA PRE
Version or Model: 10995546
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10995546
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414598703
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Complexed Prostate Specific Antigen (cPSA) Pretreatment - Atellica IM - CONS (1PK) 1 x 5mL

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?
54677	Complexed prostate specific antigen (cPSA) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of complexed prostate specific antigen (cPSA) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NAF	ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P990055	001
P990055	002
P990055	004
P990055	006
P990055	007
P990055	008
P990055	009
P990055	010
P990055	012
P990055	016
P990055	017

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 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d4384a41-8d06-483f-b3be-172f6ac53e2b
Public Version Date: November 18, 2021
Public Version Number: 6
DI Record Publish Date: November 14, 2018