FDA.reportPublic FDA data

Bifurcated Needles for Allergy Skin Testing

Primary DI
10868652000208
Brand
Bifurcated Needles for Allergy Skin Testing
Company
ROECHLING MEDICAL LANCASTER, LLC
Model
PB-02000-000-00
Catalog number
PB-02000-000-00
Device description
Bifurcated Needles for Allergy Skin Testing
Published
2020-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K031630000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031630000BIFURCATED ALLERGY SKIN TESTING NEEDLEPrecision Medical Products, Inc.2003-08-07SCL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10868652000208PrimaryGS10
00868652000201Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086865200020810868652000208
00868652000201008686520002018686520002010868652000201

GMDN Terms#

Term, Definition table
TermDefinition
Allergy testing lancetA sterile device with a sharp triangular cutting edge at the distal end designed to manually breach the epidermis to facilitate the diagnosis of allergic reactions in skin allergy testing performed by an allergist or other healthcare professional. It is held between the fingertips and pressed transiently, but firmly (not jabbed), at right angles through a drop of an allergen extract into the flexor side of the forearm of a suspected allergic individual. The tip penetrates only the most superficial layers of the skin allowing a small volume of the allergen extract to enter the skin and diffuse into the skin layers below. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
717-335-3700nadine.weiss@roechling-medical.us

Regulatory Flags#

DUNS number
130756638
Device count
100
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10868652000222Bifurcated Vaccinating NeedlesPB-01000-000-00PB-01000-000-002020-09-21

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
00365044000035Prick Lancetter™Jubilant 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