Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 Pack PS-000715

GUDID 00810031720057

Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 Pack.

Visby Medical, Inc.

Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical
Primary Device ID00810031720057
NIH Device Record Keyc455a516-eb6c-4a13-9ae1-a6445cdd3c03
Commercial Distribution StatusIn Commercial Distribution
Brand NameVisby Medical Sexual Health Vaginal Specimen Collection Kit, 50 Pack
Version Model NumberPS-000715
Catalog NumberPS-000715
Company DUNS933894748
Company NameVisby Medical, Inc.
Device Count50
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810031720002 [Unit of Use]
GS100810031720057 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LSLDna-Reagents, Neisseria

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-23
Device Publish Date2021-09-15

Devices Manufactured by Visby Medical, Inc.

10810031720061 - Visby Medical Sexual Health Test2023-04-27
00810031720071 - Visby Medical Power Adapter, Right Angle2023-04-27
00810031720002 - Visby Medical Sexual Health Click Test2021-09-23 Visby Medical Sexual Health Click Test
00810031720033 - Visby Medical Power Adapter2021-09-23 Visby Medical Power Adapter.
00810031720057 - Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 Pack2021-09-23Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 Pack.
00810031720057 - Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 Pack2021-09-23 Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 Pack.

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.