AccessGUDID - DEVICE: SpectroChip CPM Kit (10x96) (00850010566030)

GUDID

Device Identifier (DI) Information

Brand Name: SpectroChip CPM Kit (10x96)
Version or Model: 10600F
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10600F
Company Name: AGENA BIOSCIENCE, INC.

Primary DI Number: 00850010566030
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 079436896 *Terms of Use

Device Description: No description.

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?
64072	Mass spectrometry specimen target holder	A supportive device intended to hold a mass spectrometry specimen target (e.g., MALDI plate) in order to facilitate positioning and ensure correct electrical contact of the target in the mass spectrometry analyser during analysis. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DOP	MASS SPECTROMETER, CLINICAL USE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3a61941d-8b9a-4491-8a3a-0ff97b19ce2d
Public Version Date: September 16, 2020
Public Version Number: 1
DI Record Publish Date: September 08, 2020