AccessGUDID - DEVICE: Samco Clicktainer (17503025060221)

GUDID

Device Identifier (DI) Information

Brand Name: Samco Clicktainer
Version or Model: 120WHT53-1000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.

Primary DI Number: 17503025060221
Issuing Agency: GS1
Commercial Distribution End Date: July 28, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 813622313 *Terms of Use

Device Description: 120ML/53MM CLK MSU NO FUNNL ST

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):	Yes
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?
47775	General specimen container IVD, no additive/medium	An empty covered receptacle containing no additives or media intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, tissue) derived from different body regions for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMH	CONTAINER, SPECIMEN, STERILE

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: Yes

Sterilization Method [?]
Radiation Sterilization

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: 9cff47c3-c698-4174-8c63-88cc7ff6a227
Public Version Date: August 09, 2022
Public Version Number: 2
DI Record Publish Date: September 09, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
37503025060225	75	17503025060221	2022-07-28	Not in Commercial Distribution	PACKAGE
57503025060229	4	37503025060225	2022-07-28	Not in Commercial Distribution	Case