Prick Lancetter™ 8375ZA

GUDID 10365044000032

1 testing leg/tine

Jubilant Hollisterstier LLC

Allergy testing lancet
Primary Device ID10365044000032
NIH Device Record Key2ab78fb2-22e4-47c8-bb11-6a9c9a5befdc
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrick Lancetter™
Version Model Number8375ZA
Catalog Number8375ZA
Company DUNS119241112
Company NameJubilant Hollisterstier LLC
Device Count100
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
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

Customer Support Contacts

Phone800.495.7437
EmailHollisterStier@jubl.com
Phone800.495.7437
EmailHollisterStier@jubl.com
Phone800.495.7437
EmailHollisterStier@jubl.com
Phone800.495.7437
EmailHollisterStier@jubl.com
Phone800.495.7437
EmailHollisterStier@jubl.com
Phone800.495.7437
EmailHollisterStier@jubl.com
Phone800.495.7437
EmailHollisterStier@jubl.com
Phone800.495.7437
EmailHollisterStier@jubl.com
Phone800.495.7437
EmailHollisterStier@jubl.com
Phone800.495.7437
EmailHollisterStier@jubl.com
Phone800.495.7437
EmailHollisterStier@jubl.com
Phone800.495.7437
EmailHollisterStier@jubl.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100365044000035 [Primary]
GS110365044000032 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LDHSystem, Delivery, Allergen And Vaccine

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-25
Device Publish Date2024-11-15

Devices Manufactured by Jubilant Hollisterstier LLC

10365044000001 - Quintest® Multiple Skin Test Device2024-11-25 Multiple skin test system with 5 testing legs/tines
10365044000018 - ComforTen® Multiple Skin Test System2024-11-25 Multiple skin test system with 10 testing legs/tines
10365044000025 - Quintip® Skin Test Device2024-11-25 Disposable self loading test system with 1 testing leg/tine
10365044000032 - Prick Lancetter™2024-11-251 testing leg/tine
10365044000032 - Prick Lancetter™2024-11-25 1 testing leg/tine
10365044000049 - Skin Test Reservoirs2024-11-25 Holds testing antigens
00365044000059 - ComforTen® 30-hole covered tray2024-11-25 30 hole test tray
00365044000066 - ComforTen® 60-hole covered tray2024-11-25 60 hole test tray
00365044000073 - Quintest® Covered Tray2024-11-25 60 hole covered test tray

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