AccessGUDID - DEVICE: Atellica IM PSA MCM (00630414599823)

GUDID

Device Identifier (DI) Information

Brand Name: Atellica IM PSA MCM
Version or Model: 10995664
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10995664
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414599823
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Prostate Specific Antigen (PSA) - Atellica IM - Master Curve Material Kit 9 x 1 x 1.0mL

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?
38207	Total prostate specific antigen (tPSA) IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total prostate specific antigen (tPSA) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LTJ	PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P950021	015
P950021	016

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
Special Storage Condition, Specify: Store Upright, Do not freeze, Resuspend.
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: 2d895b50-ddcf-4687-a0ff-601c54b9da08
Public Version Date: November 18, 2021
Public Version Number: 6
DI Record Publish Date: November 14, 2018