OT-F³ Tip wrench

FDA registration

OT MEDICAL GMBH·1 product·🇩🇪 Germany

OT-F³ Trial Fit Gauge

FDA registration

OT MEDICAL GMBH·1 product·🇩🇪 Germany

TecLine

FDA registration

OT MEDICAL GMBH·2 products·🇩🇪 Germany

OTF / Gabapentin assay DLJ / Calibrators, drug specific LAS / Drug specific control materials

FDA registration

MONOCENT INC.·3 products·🇺🇸 United States

Gabapentin(GAB) Rapid Test Cassette

FDA registration

ACRO BIOTECH Inc.·1 product·🇺🇸 United States

Ranfac Aspiration Needle, 8GA X 23CM, RAN-823-OT, F/G, Sterile

FDA UDI

RANFAC CORP.·00857878007507·RAN-823-OT, F/G, Sterile Part Number 74315-01M

RIN-15-60-OT

FDA UDI

RANFAC CORP.·00850023741257·RIN-15-60-OT F/G, STERILE P/N 74388-01M

ARK™ Gabapentin Assay

FDA UDI

ARK DIAGNOSTICS INC·00858724003049·The ARK™ Gabapentin Assay is a homogeneous enzy...

ARK™ Gabapentin Assay (c-pack)

FDA UDI

ARK DIAGNOSTICS INC·00858724003261·The ARK™ Gabapentin Assay is a homogeneous enzy...

ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ARK Gabapentin Assay

FDA registration

ARK DIAGNOSTICS INC·3 products·🇺🇸 United States

Gabapentin Assay

FDA classification

FDA Class 2 ·Gabapentin Assay

BTF-HM-3, Hummingbird Trifurcated Extension Set

FDA registration

MPS PHARMA & MEDICAL, INC.·1 product·🇺🇸 United States

CTF OMEGA

FDA registration

CTF MEG Neuro Innovations Inc·2 products·🇨🇦 Canada

MONTEFARMACO OTC SPA

Manufacturer

🇮🇹 Italy·17 Basic UDI-DIs·17 Devices·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A., ICIM S.P.A., ICIM S.P.A., ICIM S.P.A., and IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.

OFF CARR Srl

Manufacturer

🇮🇹 Italy·1 Basic UDI-DI·12 Devices

MPS34520 (TM) - BTF-HM-3, Hummingbird Trifurcated Extension Se

FDA registration

Isomedix Operations, Inc.·1 product·🇺🇸 United States

Reinfusion Bag 1000 mL

FDA registration

FENWAL, INC.·1 product·🇺🇸 United States

Reinfusion Bag 1000 mL

FDA registration

FRESENIUS HEMOCARE GMBH·1 product·🇩🇪 Germany

NUTRA ESSENTIAL OTC, S.L.

Manufacturer

🇪🇸 Spain