AccessGUDID - DEVICE: Accessorie (04250317537058)

GUDID

Device Identifier (DI) Information

Brand Name: Accessorie
Version or Model: 34760
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 34760
Company Name: Chromsystems Instruments + Chemicals GmbH

Primary DI Number: 04250317537058
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 328712260 *Terms of Use

Device Description: Pierceable Heat Seals for 96 Well Plates Vitamins A and E in serum/plasma, Automated with 96 well filter plates

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?
61296	Microplate IVD	A plate with multiple wells designed to contain small volumes of clinical specimens, reagents, or other materials for testing procedures performed by a laboratory analyser. It is typically made of sterilizable plastic material (e.g., polypropylene) and is used with manual or automated analysers. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JOA	Acid, Trifluoroacetic, Vitamin A, Hexane Extraction

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
Storage Environment Temperature: between 18 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 6 pcs.

Device Record Status

Public Device Record Key: cbc1e69e-a4f4-4fce-acd3-d97cdbc33989
Public Version Date: September 04, 2020
Public Version Number: 1
DI Record Publish Date: August 27, 2020