AccessGUDID - DEVICE: SALI-TUBES 500 (00404847441574)

GUDID

Device Identifier (DI) Information

Brand Name: SALI-TUBES 500
Version or Model: SLV-4157
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SLV-4157
Company Name: DRG Instruments Gesellschaft mit beschränkter Haftung

Primary DI Number: 00404847441574
Issuing Agency: GS1
Commercial Distribution End Date: December 02, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 317134468 *Terms of Use

Device Description: Sampling tubes for collection of saliva samples to be used in the DRG Salivary Immunoassays

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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
JLS	RADIOIMMUNOASSAY, PROGESTERONE

FDA Premarket Submission

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

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: 9ca1b542-4ada-4ed9-9771-ad187d05ea78
Public Version Date: December 03, 2024
Public Version Number: 2
DI Record Publish Date: June 07, 2021