FDA.reportPublic FDA data

Prick Lancetter™

Primary DI
00365044000035
Brand
Prick Lancetter™
Company
Jubilant Hollisterstier LLC
Model
8375ZA
Catalog number
8375ZA
Device description
1 testing leg/tine
Published
2024-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LDHSystem, Delivery, Allergen And Vaccine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDHSystem, Delivery, Allergen And Vaccine

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K953939000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K953939000QUINTESTBayer Corp.1995-11-13SCL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00365044000035PrimaryGS10
10365044000032Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00365044000035003650440000353650440000350365044000035
1036504400003210365044000032

Contacts#

Phone, Email table
PhoneEmail
800.495.7437HollisterStier@jubl.com

Regulatory Flags#

DUNS number
119241112
Device count
100
Combination product
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00365044000080ComforTen® 60-hole covered tray800000137280000013722026-03-02
00365044000004Quintest® Multiple Skin Test Device8392ZA8392ZA2024-11-15
00365044000011ComforTen® Multiple Skin Test System80000000021800000000212024-11-15
00365044000028Quintip® Skin Test Device8400ZA8400ZA2024-11-15
00365044000042Skin Test Reservoirs8924ZA8924ZA2024-11-15
10365044000001Quintest® Multiple Skin Test Device8392ZA8392ZA2024-11-15
10365044000018ComforTen® Multiple Skin Test System80000000021800000000212024-11-15
10365044000025Quintip® Skin Test Device8400ZA8400ZA2024-11-15
10365044000032Prick Lancetter™8375ZA8375ZA2024-11-15
10365044000049Skin Test Reservoirs8924ZA8924ZA2024-11-15
00365044000059ComforTen® 30-hole covered tray8406ZA8406ZA2024-11-15
00365044000066ComforTen® 60-hole covered tray8407ZA8407ZA2024-11-15
00365044000073Quintest® Covered Tray8930ZA8930ZA2024-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00365044000004Quintest® Multiple Skin Test DeviceJubilant Hollisterstier LLCLDH2024-11-15
00365044000011ComforTen® Multiple Skin Test SystemJubilant Hollisterstier LLCLDH2024-11-15
00365044000028Quintip® Skin Test DeviceJubilant Hollisterstier LLCLDH2024-11-15
00365044000042Skin Test ReservoirsJubilant Hollisterstier LLCLDH2024-11-15
10365044000001Quintest® Multiple Skin Test DeviceJubilant Hollisterstier LLCLDH2024-11-15
10365044000018ComforTen® Multiple Skin Test SystemJubilant Hollisterstier LLCLDH2024-11-15
10365044000025Quintip® Skin Test DeviceJubilant Hollisterstier LLCLDH2024-11-15
10365044000032Prick Lancetter™Jubilant Hollisterstier LLCLDH2024-11-15
10365044000049Skin Test ReservoirsJubilant Hollisterstier LLCLDH2024-11-15
00365044000059ComforTen® 30-hole covered trayJubilant Hollisterstier LLCLDH2024-11-15
00365044000066ComforTen® 60-hole covered trayJubilant Hollisterstier LLCLDH2024-11-15
00365044000073Quintest® Covered TrayJubilant Hollisterstier LLCLDH2024-11-15
B682ALK8004AccuTest-1™MEDSCIENCE RESEARCH GROUP, INC.LDH2024-04-16
ALK80001AccuTest-1™MEDSCIENCE RESEARCH GROUP, INC.LDH2024-04-16
B682ALK08H006AccuTest-8™MEDSCIENCE RESEARCH GROUP, INC.LDH2024-03-15
B682ALK10H006AccuTest-10™MEDSCIENCE RESEARCH GROUP, INC.LDH2024-03-15
B682ALK48T001AccuTest™ Test TrayMEDSCIENCE RESEARCH GROUP, INC.LDH2024-03-15
B682ALK60T001AccuTest™ Test TrayMEDSCIENCE RESEARCH GROUP, INC.LDH2024-03-15
B682ALK8002AccuTest-1™MEDSCIENCE RESEARCH GROUP, INC.LDH2024-03-15
00300858999991BCG Vaccine (Multiple Puncture Device)Merck Sharp & Dohme LLCLDH2023-04-10
60300858999993BCG Vaccine (Multiple Puncture Device)MERCK SHARP & DOHME CORP.LDH2023-04-10
B6828002ST-9MEDSCIENCE RESEARCH GROUP, INC.LDH2021-09-30
B68280021ST-9MEDSCIENCE RESEARCH GROUP, INC.LDH2021-09-30
10854498007242SmartPracticeSmarthealth, Inc.LDH2020-12-15
10854498007266SmartPracticeSmarthealth, Inc.LDH2020-12-15
10854498007365SmartPracticeSmarthealth, Inc.LDH2020-12-15
10854498007372SmartPracticeSmarthealth, Inc.LDH2020-12-15
10854498007389SmartPracticeSmarthealth, Inc.LDH2020-12-15
00854498007399SmartPracticeSmarthealth, Inc.LDH2020-12-15
10854498007402SmartPracticeSmarthealth, Inc.LDH2020-12-15