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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Coxiella burnetii (Q-Fever) Phase 2 IgG ELISA - 00404847451894

The Coxiella burnetii (Q-Fever) Phase 2 IgG ELISA is intended for the qualitative determination of IgG class antibodies against Coxiella burnetii (Q-Fever) Phase 2 in human serum or plasma (citrate, heparin).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-5189
Not in Commercial Distribution

  • 00404847451894 ()
EIA-5189

  • Coxiella burnetii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Coxiella burnetii (Q-Fever) Phase 1 IgG ELISA - 00404847451887

The Coxiella burnetii (Q-Fever) Phase 1 IgG ELISA is intended for the qualitative determination of IgG class antibodies against Coxiella burnetii (Q-Fever) Phase 1 in human serum or plasma (citrate, heparin).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-5188
Not in Commercial Distribution

  • 00404847451887 ()
EIA-5188

  • Coxiella burnetii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Coxiella burnetii (Q-Fever) Phase 2 IgG ELISA - 04048474051896

The Coxiella burnetii (Q-Fever) Phase 2 IgG ELISA is intended for the qualitative determination of IgG class antibodies against Coxiella burnetii (Q-Fever) Phase 2 in human serum or plasma (citrate, heparin).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-5189
In Commercial Distribution

  • 04048474051896 ()
EIA-5189

  • Coxiella burnetii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Coxiella burnetii (Q-Fever) Phase 1 IgG ELISA - 04048474051889

The Coxiella burnetii (Q-Fever) Phase 1 IgG ELISA is intended for the qualitative determination of IgG class antibodies against Coxiella burnetii (Q-Fever) Phase 1 in human serum or plasma (citrate, heparin).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-5188
In Commercial Distribution

  • 04048474051889 ()
EIA-5188

  • Coxiella burnetii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Coxiella burnetii (Q-Fever) Phase 2 IgG ELISA - 00840239051899

The Coxiella burnetii (Q-Fever) Phase 2 IgG ELISA is intended for the qualitative determination of IgG class antibodies against Coxiella burnetii (Q-Fever) Phase 2 in human serum or plasma (citrate, heparin).
DRG International Inc
EIA-5189
In Commercial Distribution

  • 00840239051899 ()
EIA-5189

  • Coxiella burnetii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Coxiella burnetii (Q-Fever) Phase 1 IgG ELISA - 00840239051882

The Coxiella burnetii (Q-Fever) Phase 1 IgG ELISA is intended for the qualitative determination of IgG class antibodies against Coxiella burnetii (Q-Fever) Phase 1 in human serum or plasma (citrate, heparin).
DRG International Inc
EIA-5188
In Commercial Distribution

  • 00840239051882 ()
EIA-5188

  • Coxiella burnetii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

CHORUS Q FEVER PHASE II IgG - 08033891322083

No Description
DIESSE DIAGNOSTICA SENESE SPA
81171
In Commercial Distribution

  • 08033891322083 ()
81171

  • Coxiella burnetii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

NovaLisa Coxiella burnetii (Q-Fever) Phase 2 IgG - ENTICOX2G0600

The Coxiella burnetii (Q-Fever) Phase 2 IgG ELISA is intended for the qualitative determination of IgG class antibodies against Coxiella burnetii (Q-Fever) Phase 2 in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
COX2G060
In Commercial Distribution

  • ENTICOX2G0600 ()
COX2G0600

  • Coxiella burnetii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

NovaLisa Coxiella burnetii (Q-Fever) Phase 1 IgG - ENTICOX1G0600

The Coxiella burnetii (Q-Fever) Phase 1 IgG ELISA is intended for the qualitative determination of IgG class antibodies against Coxiella burnetii (Q-Fever) Phase 1 in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
COX1G060
In Commercial Distribution

  • ENTICOX1G0600 ()
COX1G0600

  • Coxiella burnetii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

C. burnetii 12 Well 10 pk - 00813545026073

No Description
SCIMEDX CORPORATION
I-QFB01X
In Commercial Distribution

  • 00813545026073 ()
I-QFB01X

  • Coxiella burnetii total antibody IVD, kit, fluorescent immunoassay

JBAIDS - 00851458005013

JBAIDS IVD Q Fever Detection Kit
BIOFIRE DEFENSE, LLC
JRPD-ASY-0016
Not in Commercial Distribution

  • 00851458005013 ()
JRPD-ASY-0016

  • Coxiella burnetii nucleic acid IVD, kit, nucleic acid technique (NAT)

CytoCell - 05055844905948

Del(20q) Deletion FISH Probe Kit
CYTOCELL LIMITED
USA-LPH020
In Commercial Distribution

USA-LPH020

  • Myelodysplastic syndrome (MDS) IVD, probe

Cytocell Aquarius - 05055844901575

Del(20q) Deletion FISH Probe Kit
CYTOCELL LIMITED
USA-LPH020
In Commercial Distribution

  • 05055844901575 ()
USA-LPH020

  • Myelodysplastic syndrome (MDS) IVD, probe

CytoCell - 05055844923850

Del(20q) Deletion FISH Probe Kit (IVD (USA))
CYTOCELL LIMITED
USA-LPH020
In Commercial Distribution



  • Myelodysplastic syndrome (MDS) IVD, probe

N/A - 00889024408593

No Description
Zimmer, Inc.
6728-95
In Commercial Distribution

  • 00889024408593 ()

  • Lumen/Inner Diameter: 28 Millimeter
  • O.D. Size Q
00-6728-095-00

  • Non-constrained polyethylene acetabular liner

N/A - 00889024408487

No Description
Zimmer, Inc.
6726-95
In Commercial Distribution

  • 00889024408487 ()

  • O.D. Size Q
  • Lumen/Inner Diameter: 26 Millimeter
00-6726-095-00

  • Non-constrained polyethylene acetabular liner

N/A - 00889024408364

No Description
Zimmer, Inc.
6722-95
In Commercial Distribution

  • 00889024408364 ()

  • Lumen/Inner Diameter: 22 Millimeter
  • O.D. Size Q
00-6722-095-00

  • Non-constrained polyethylene acetabular liner

N/A - 00889024128453

No Description
Zimmer, Inc.
6732-95
In Commercial Distribution

  • 00889024128453 ()

  • Lumen/Inner Diameter: 32 Millimeter
  • O.D. Size Q
00-6732-095-00

  • Non-constrained polyethylene acetabular liner

Unimed - 06945664824972

SpO2 interface cable/安维生-Philips/3.0M/087
Unimed Medical Supplies, Inc.
U710-169
In Commercial Distribution

  • 06945664824972 ()


  • Electrical-only medical device connection cable, reusable

Unimed - 06945664824958

SpO2 interface cable/安维生-Nellcor/3.0M/103X
Unimed Medical Supplies, Inc.
U710-170
In Commercial Distribution

  • 06945664824958 ()


  • Electrical-only medical device connection cable, reusable

Q Pedicle Instruments - 10888857553033

Q Awl
K2M, INC.
48111003
In Commercial Distribution

  • 10888857553033 ()
48111003

  • Bone awl, reusable

Centurion - 00653160217698

SUB Q
CENTURION MEDICAL PRODUCTS CORPORATION
MNS6465
In Commercial Distribution

  • 10653160217695 ()
  • 00653160217698 ()
MNS6465

  • General surgical procedure kit, non-medicated, single-use

Surgical Microscope MM80/YOH - 04589698450268

No Description
MITAKA KOHKI CO., LTD.
MM80/YOH
In Commercial Distribution

  • 04589698450268 ()


  • General-purpose surgical microscope
  • Neurosurgical microscope
  • Microscope objective
  • ENT surgical microscope
  • Surgical microscope fluorescent angiography system

Surgical Microscope MM51/YOH - 04589698450176

The MM51/YOH is for use as surgical microscope designed to magnify minute structuresin the fields for surgery.
MITAKA KOHKI CO., LTD.
MM51/YOH
In Commercial Distribution

  • 04589698450176 ()


  • Surgical microscope fluorescent angiography system
  • ENT surgical microscope
  • Surgical microscope stand
  • Microscope objective
  • Neurosurgical microscope
  • General-purpose surgical microscope

Surgical Microscope MM90/YOH - 04589698450251

No Description
MITAKA KOHKI CO., LTD.
MM90/YOH
In Commercial Distribution

  • 04589698450251 ()


  • General-purpose surgical microscope
  • Neurosurgical microscope
  • Microscope objective
  • ENT surgical microscope
  • Surgical microscope fluorescent angiography system

Caribbian Blue Tinted Monomer - D851Q0

Tinted Liquid
JBC and Company
Q
In Commercial Distribution

  • D851Q0 ()
Q

  • Dental appliance fabrication material, resin

Unimed - 06945664821131

Reusable SpO2 Sensor/奥生科技/Finger clip/Adult/3.0M/LP6-40B
Unimed Medical Supplies, Inc.
U410-159D
In Commercial Distribution

  • 06945664821131 ()


  • Pulse oximeter probe, reusable

Unimed - 06945664817660

SpO2 interface cable/安维生/3.0M/073/客户订做
Unimed Medical Supplies, Inc.
U710-172
In Commercial Distribution

  • 06945664817660 ()


  • Electrical-only medical device connection cable, reusable

Q Pedicle Instruments - 10888857553026

Q Lumbar Probe
K2M, INC.
48111004
In Commercial Distribution

  • 10888857553026 ()
48111004

  • Stereotactic surgery system probe, reusable

Q Pedicle Instruments - 10888857553019

Q Thoracic Probe
K2M, INC.
48111005
In Commercial Distribution

  • 10888857553019 ()
48111005

  • Stereotactic surgery system probe, reusable

Q Pedicle Instruments - 10888857553002

Q Drill Stop
K2M, INC.
48111011
In Commercial Distribution

  • 10888857553002 ()
48111011

  • Surgical instrument/implant depth limiter, reusable

Q Pedicle Instruments - 10888857552944

Q Ratchet T-Handle
K2M, INC.
48111100
In Commercial Distribution

  • 10888857552944 ()
48111100

  • Surgical instrument handle, non-torque-limiting

Q Pedicle Instruments - 10888857552388

ES2 Q Screwdriver
K2M, INC.
48113200
In Commercial Distribution

  • 10888857552388 ()
48113200

  • Surgical screwdriver, reusable

Q Pedicle Instruments - 10888857552333

Everest Q Screwdriver
K2M, INC.
48113400
In Commercial Distribution

  • 10888857552333 ()
48113400

  • Surgical screwdriver, reusable

Q Pedicle Instruments - 10888857552227

Q Navigation Adaptor
K2M, INC.
48115000
In Commercial Distribution

  • 10888857552227 ()
48115000

  • Orthopaedic implant-instrument extension adaptor, reusable

Q Pedicle Instruments - 10888857552159

Q Spade Blade
K2M, INC.
48861001-GS
In Commercial Distribution

  • 10888857552159 ()
48861001-GS

  • Scalpel, single-use

Quantum - D8255126000000

Q Fit Analog
QUANTUM BIOENGINEERING LTD.
512-600-000
In Commercial Distribution

  • D8255126000000 ()

  • Length: 5 Millimeter
  • Outer Diameter: 3 Millimeter
512-600-000

  • Dental implant analog

Medline Industries, Inc. - 10888277919174

SUB Q KIT
MEDLINE INDUSTRIES, INC.
DYKM1129
In Commercial Distribution

  • 10888277919174 ()
DYKM1129

  • General surgical procedure kit, non-medicated, single-use

Arjo Wiggins Medical, Inc. - 00815588020209

22 10X10,1000_CASE Q
STERIMED INC.
1010221010
In Commercial Distribution

  • 00815588020209 ()
  • 00815588020193 ()
1010221010

  • Sterilization packaging, single-use

CORE - 07613327592979

Core Q Footswitch
STRYKER CORPORATION
5502007700
In Commercial Distribution

  • 07613327592979 ()
5502-007-000

  • Foot-switch, electrical

N/A - 07613327503265

Q Guidance System
Stryker Leibinger GmbH & Co. KG
8900-100-000
In Commercial Distribution

  • 07613327503265 ()
8900-100-000

  • Optical surgical navigation device tracking system

Vision 2 - 00817978021971

Salmonella H: q
PRO-LAB, INCORPORATED
PLA197
In Commercial Distribution

  • 00817978021971 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent

CorTemp - 00857414006049

Lease Handheld electronic device which receives temperature sensitive crystal oscillations via near field magnetic link. The oscillation measurement is converted to a temperature using the sensor's calibration number.
H Q, INC
HT150001L
In Commercial Distribution

  • 00857414006049 ()


  • Temperature telemetric monitoring system transmitter

CorTemp - 00857414006032

300kHz Handheld electronic device which receives temperature sensitive crystal oscillations via near field magnetic link. The oscillation measurement is converted to a temperature using the sensor's calibration number.
H Q, INC
HT150032
In Commercial Distribution

  • 00857414006032 ()


  • Temperature telemetric monitoring system transmitter

CorTemp - 00857414006025

Handheld electronic device which receives temperature sensitive crystal oscillations via near field magnetic link. The oscillation measurement is converted to a temperature using the sensor's calibration number.
H Q, INC
HT150001
In Commercial Distribution

  • 00857414006025 ()


  • Temperature telemetric monitoring system transmitter

CorTemp - 00857414006018

A small capsule shaped sensor which contains an electronic thermometer. The sensor operates at 300 kHz frequency and transmits via near field magnetic link..
H Q, INC
HT150031
In Commercial Distribution

  • 00857414006018 ()


  • Temperature telemetric monitoring system transmitter

CorTemp - 00857414006001

A small capsule shaped sensor which contains an electronic thermometer. The sensor operates at 262 kHz frequency and transmits via near field magnetic link.
H Q, INC
HT150002
In Commercial Distribution

  • 00857414006001 ()


  • Temperature telemetric monitoring system transmitter

Q UROLOGICAL FUSELAGE AGUAMEDICINA - 10811503033528

Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP377SS0724
In Commercial Distribution

  • 10811503033528 ()
NP377SS0724

  • Polymeric ureteral stent

Q UROLOGICAL FUSELAGE AGUAMEDICINA - 10811503033511

Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP377SS0726
In Commercial Distribution

  • 10811503033511 ()
NP377SS0726

  • Polymeric ureteral stent

Q UROLOGICAL FUSELAGE AGUAMEDICINA - 10811503033481

Ureteral Stent - 4 Pack
Q UROLOGICAL CORPORATION
NP378SS0724
In Commercial Distribution

  • 10811503033481 ()


  • Polymeric ureteral stent
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