AccessGUDID - DEVICE: Insert, 24 Well, PET 0.4µm, TP (04038917371346)

GUDID

Device Identifier (DI) Information

Brand Name: Insert, 24 Well, PET 0.4µm, TP
Version or Model: 83.3932.041
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 83.3932.041
Company Name: Sarstedt Aktiengesellschaft & Co.KG

Primary DI Number: 04038917371346
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 48
Labeler D-U-N-S® Number*: 388000270 *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:	Yes
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?
43344	Tissue culture/microbiology petri dish, single-use	A device formed as a round and shallow-sided dish intended to be used to grow and contain tissue and/or microbial cultures for laboratory procedures; it is not intended for in vitro fertilization (IVF). It is designed to fit into a range of laboratory instruments and analysers where various processes can be carried out. The device is typically made of glass or plastic and includes a cover; it may be colour coded. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KIZ	DISH, TISSUE CULTURE

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: Yes
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: 8d5f0e44-87d4-4830-a76c-69873e6d7d56
Public Version Date: August 18, 2023
Public Version Number: 3
DI Record Publish Date: November 30, 2022