AccessGUDID - DEVICE: Atellica IM Calibrator Q (00630414598444)

GUDID

Device Identifier (DI) Information

Brand Name: Atellica IM Calibrator Q
Version or Model: 10995517
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10995517
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414598444
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Calibrator Q Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL

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?
38208	Total prostate specific antigen (tPSA) IVD, calibrator	A material which is used to establish known points of reference for 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
MTF	TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P950021	002
P950021	006
P950021	007
P950021	011

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: 5cb17a82-3530-4a37-809d-8467521156fd
Public Version Date: November 18, 2021
Public Version Number: 6
DI Record Publish Date: December 27, 2017