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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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PRAME [EPR20330] - 00847627025067

No Description
BIOCARE MEDICAL LLC
AVI3252G
In Commercial Distribution

  • 00847627025067 ()


  • Preferentially expressed antigen in melanoma (PRAME) IVD, antibody

PRAME [EPR20330] - 00847627025050

No Description
BIOCARE MEDICAL LLC
API3252AA
In Commercial Distribution

  • 00847627025050 ()


  • Preferentially expressed antigen in melanoma (PRAME) IVD, antibody

PRAME [EPR20330] - 00847627025043

No Description
BIOCARE MEDICAL LLC
ACI3252A
In Commercial Distribution

  • 00847627025043 ()


  • Preferentially expressed antigen in melanoma (PRAME) IVD, antibody

Anti-PRAME (EPR20330) Rabbit Monoclonal Primary Antibody - 07613336206034

No Description
Ventana Medical Systems, Inc.
09592245001
In Commercial Distribution

  • 07613336206034 ()
09592245001

  • Preferentially expressed antigen in melanoma (PRAME) IVD, antibody

Anti-PRAME (EPR20330) Rabbit Monoclonal Primary Antibody - 07613336206027

No Description
Ventana Medical Systems, Inc.
09592237001
In Commercial Distribution

  • 07613336206027 ()
09592237001

  • Preferentially expressed antigen in melanoma (PRAME) IVD, antibody

TintoFast Prame (RBT-PRAME) - B502BSB377470

TintoFast Prame is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
BSB-3774-7
In Commercial Distribution

  • B502BSB377470 ()

  • Total Volume: 7 Milliliter
BSB-3774-7

  • Preferentially expressed antigen in melanoma (PRAME) IVD, antibody

TintoFast Prame (RBT-PRAME) - B502BSB377430

TintoFast Prame is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
BSB-3774-3
In Commercial Distribution

  • B502BSB377430 ()

  • Total Volume: 3 Milliliter
BSB-3774-3

  • Preferentially expressed antigen in melanoma (PRAME) IVD, antibody

IHC - 00810170551932

RM55-01: PRAME, Clone EPR20330, 1mL Concentrate
Slmp, LLC
Antibody PRAME Conc Rabbit Monoclonal 1mL
In Commercial Distribution

  • 00810170551932 ()
RM60-1

  • Preferentially expressed antigen in melanoma (PRAME) IVD, antibody

IHC - 00810170551925

RM55-05: PRAME, Clone EPR20330, .5mL Concentrate
Slmp, LLC
(BTO) Antibody PRAME Conc Rabbit Monoclonal 0.5mL
In Commercial Distribution

  • 00810170551925 ()
RM60-05

  • Preferentially expressed antigen in melanoma (PRAME) IVD, antibody

IHC - 00810170551918

RM55-10: PRAME, Clone EPR20330, 10mL RTU
Slmp, LLC
(BTO) Antibody PRAME RTU Rabbit Monoclonal 10mL
In Commercial Distribution

  • 00810170551918 ()
RM55-10

  • Preferentially expressed antigen in melanoma (PRAME) IVD, antibody

Rabbit Monoclonal Anti-Human PRAME - 00810138720042

Rabbit Monoclonal Anti-Human PRAME, concentrated
Epitomics Inc.
AC-0398CMBULK
In Commercial Distribution

  • 00810138720042 ()


  • Preferentially expressed antigen in melanoma (PRAME) IVD, antibody

Rabbit Monoclonal Anti-Human PRAME - 00810138720035

Rabbit Monoclonal Anti-Human PRAME, concentrated
Epitomics Inc.
AC-0398BULK
In Commercial Distribution

  • 00810138720035 ()


  • Preferentially expressed antigen in melanoma (PRAME) IVD, antibody

Rabbit Monoclonal Anti-Human PRAME - 00810138720028

Rabbit Monoclonal Anti-Human PRAME, 0.5 mL concentrated
Epitomics Inc.
AC-0398B
In Commercial Distribution

  • 00810138720028 ()

  • Total Volume: 0.5 Milliliter


  • Preferentially expressed antigen in melanoma (PRAME) IVD, antibody

Rabbit Monoclonal Anti-Human PRAME - 00810138720011

Rabbit Monoclonal Anti-Human PRAME, 0.1 mL concentrated
Epitomics Inc.
AC-0398A
In Commercial Distribution

  • 00810138720011 ()

  • Total Volume: 0.1 Milliliter


  • Preferentially expressed antigen in melanoma (PRAME) IVD, antibody

Rabbit Monoclonal Anti-Human PRAME - 00810138720004

Rabbit Monoclonal Anti-Human PRAME, 1mL concentrated
Epitomics Inc.
AC-0398
In Commercial Distribution

  • 00810138720004 ()

  • Total Volume: 1 Milliliter


  • Preferentially expressed antigen in melanoma (PRAME) IVD, antibody

TintoFast Prame (RBT-PRAME) - B502BSB3774150

TintoFast Prame is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
BSB-3774-15
In Commercial Distribution

  • B502BSB3774150 ()

  • Total Volume: 15 Milliliter
BSB-3774-15

  • Preferentially expressed antigen in melanoma (PRAME) IVD, antibody

WALGREENS - 00311917212715

WALG CRUTCH ACCESSORY KIT(2 Arm Cushions, 2 Hand Grips, 2 Tips)
WALGREEN CO.
586508
In Commercial Distribution

  • 00311917212715 ()
  • 10311917212712 ()


  • Walking aid handgrip
  • Walking aid tip
  • Crutch pad

Walgreens - 00311917187563

WALG CRUTCH ACCESSORY KIT
WALGREEN CO.
954484
In Commercial Distribution

  • 10311917187560 ()
  • 00311917187563 ()


  • Walking aid handgrip
  • Walking aid tip
  • Crutch pad

In Reach - 00863152000331

Cone Beam Computed Tomography diagnostic extremity imaging system. Compatible with 230 Volts power outlet. 3D field of view of 17.2 cm (height) x 16cm (diameter) accommodates imaging of hand, wrist, forearm, elbow, knee, lower leg or foot. Bore platforms are interchangeable to accommodate patient size and body part. Self-shielded to reduce scatter radiation during scan. Scan time is less than 30 seconds. Scans are output as DICOM compatible 3D reconstructions, 0.2 mm multi-planar slices. In Reach system includes acquisition station and visualization station enabled with CubeVue visualization software.
CURVEBEAM, LLC
1020-230
In Commercial Distribution

  • 00863152000331 ()


  • Limited-view-field CT system

In Reach - 00863152000324

Cone Beam Computed Tomography diagnostic extremity imaging system. Compatible with 115 Volts power outlet. 3D field of view of 17.2 cm (height) x 16cm (diameter) accommodates imaging of hand, wrist, forearm, elbow, knee, lower leg or foot. Bore platforms are interchangeable to accommodate patient size and body part. Self-shielded to reduce scatter radiation during scan. Scan time is less than 30 seconds. Scans are output as DICOM compatible 3D reconstructions, 0.2 mm multi-planar slices. In Reach system includes acquisition station and visualization station enabled with CubeVue visualization software.
CURVEBEAM, LLC
1020-115
In Commercial Distribution

  • 00863152000324 ()


  • Limited-view-field CT system

IN Clips - 07290109742427

IN Clips
BHI IMPLANTS LTD
1
In Commercial Distribution

  • 07290109742427 ()
BH-IB81

  • Dental implant suprastructure, permanent, preformed

Cleaning Brush, Long - 00848253004020

No Description
Freudenberg Medical, LLC
IN 4063
In Commercial Distribution

  • 00848253004020 ()
IN 4063

  • Airway device cleaning utensil, invasive

Cleaning Brush, Standard - 00848253004013

No Description
Freudenberg Medical, LLC
IN 4062
In Commercial Distribution

  • 00848253004013 ()
IN 4062

  • Airway device cleaning utensil, invasive

INTRODUCER NEEDLE - 08033055147293

INTRODUCER NEEDLE 100MM PER AGO 14G
H.S. HOSPITAL SERVICE SPA
INTRODUCER NEEDLE
In Commercial Distribution

  • 48033055147291 ()
  • 08033055147293 ()

  • Length: 100 Millimeter
IN 14100N

  • Interventional radiology percutaneous-access kit, single-use

INTRODUCER NEEDLE - 08033055145398

INTRODUCER NEEDLE 150MM PER AGO 18G
H.S. HOSPITAL SERVICE SPA
INTRODUCER NEEDLE
In Commercial Distribution

  • 48033055145396 ()
  • 08033055145398 ()
  • 38033055145399 ()

  • Length: 75 Millimeter
IN 18150N

  • Interventional radiology percutaneous-access kit, single-use

INTRODUCER NEEDLE - 08033055145442

INTRODUCER NEEDLE 150MM PER AGO 16G
H.S. HOSPITAL SERVICE SPA
INTRODUCER NEEDLE
In Commercial Distribution

  • 38033055145443 ()
  • 08033055145442 ()
  • 48033055145440 ()

  • Length: 150 Millimeter
IN 16150N

  • Interventional radiology percutaneous-access kit, single-use

INTRODUCER NEEDLE - 08033055145435

INTRODUCER NEEDLE 100MM PER AGO 16G
H.S. HOSPITAL SERVICE SPA
INTRODUCER NEEDLE
In Commercial Distribution

  • 38033055145436 ()
  • 08033055145435 ()
  • 48033055145433 ()

  • Length: 100 Millimeter
IN 16100N

  • Interventional radiology percutaneous-access kit, single-use

INTRODUCER NEEDLE - 08033055145374

INTRODUCER NEEDLE 100MM PER AGO 18G
H.S. HOSPITAL SERVICE SPA
INTRODUCER NEEDLE
In Commercial Distribution

  • 38033055145375 ()
  • 08033055145374 ()
  • 48033055145372 ()

  • Length: 100 Millimeter
IN 18100N

  • Interventional radiology percutaneous-access kit, single-use

INTRODUCER NEEDLE - 08033055141260

INTRODUCER NEEDLE 50MM PER AGO 18G
H.S. HOSPITAL SERVICE SPA
INTRODUCER NEEDLE
In Commercial Distribution

  • 48033055141268 ()
  • 08033055141260 ()

  • Length: 50 Millimeter
IN 1805N

  • Interventional radiology percutaneous-access kit, single-use

INTRODUCER NEEDLE - 08033055141239

INTRODUCER NEEDLE 50MM PER AGO 16G
H.S. HOSPITAL SERVICE SPA
INTRODUCER NEEDLE
In Commercial Distribution

  • 38033055141230 ()
  • 08033055141239 ()
  • 48033055141237 ()

  • Length: 50 Millimeter
IN 1605N

  • Interventional radiology percutaneous-access kit, single-use

INTRODUCER NEEDLE - 08033055141208

INTRODUCER NEEDLE 75MM PER AGO 14G
H.S. HOSPITAL SERVICE SPA
INTRODUCER NEEDLE
In Commercial Distribution

  • 48033055141206 ()
  • 08033055141208 ()
  • 38033055141209 ()

  • Length: 75 Millimeter
IN 14075N

  • Interventional radiology percutaneous-access kit, single-use

INTRODUCER NEEDLE - 08033055141192

INTRODUCER NEEDLE 50MM PER AGO 14G
H.S. HOSPITAL SERVICE SPA
INTRODUCER NEEDLE
In Commercial Distribution

  • 48033055141190 ()
  • 08033055141192 ()

  • Length: 50 Millimeter
IN 1405N

  • Interventional radiology percutaneous-access kit, single-use

INTRODUCER NEEDLE - 08058983741795

INTRODUCER NEEDLE 100MM PER AGO 20G
H.S. HOSPITAL SERVICE SPA
INTRODUCER NEEDLE
In Commercial Distribution

  • 48058983741793 ()
  • 08058983741795 ()

  • Length: 100 Millimeter
IN 20100N

  • Interventional radiology percutaneous-access kit, single-use

INTRODUCER NEEDLE - 08058983744192

INTRODUCER NEEDLE 150MM PER AGO 20G
H.S. HOSPITAL SERVICE SPA
INTRODUCER NEEDLE
In Commercial Distribution

  • 48058983744190 ()
  • 08058983744192 ()

  • Length: 150 Millimeter
IN 20150N

  • Interventional radiology percutaneous-access kit, single-use

Crypto/Giardia Human Fecal Direct Fluorescent Antigen Detection Kit - 00854624006005

No Description
IVD RESEARCH, INC.
C/G-DFA
In Commercial Distribution

  • 00854624006005 ()
C/G-DFA

  • Cryptosporidium species antigen IVD, kit, direct fluorescent test (DFT)
  • Giardia lamblia antigen IVD, kit, direct fluorescent test (DFT)

Unimed - 06936735465095

'One-piece ECG Monitor Cable AAMI
Unimed Medical Supplies, Inc.
E10R-SH2-B/I-N
In Commercial Distribution

  • 06936735465095 ()


  • Electrocardiographic lead set, reusable

SHARPER IMAGE - 06936189900067

No Description
GUANGDONG OKAY TECHNOLOGY CO.,LTD.
25 in
In Commercial Distribution

  • 06936189900067 ()


  • Hand-held electric massager

In Touch Lancing Device - 00853553005189

Black Lancing Device
LIVONGO HEALTH, INC
In Touch
In Commercial Distribution

  • 00853553005189 ()
OFG00204

  • Manual blood lancing device, reusable

In Touch Glucose Control Solution - 00853553005158

In Touch Control solution with 1 bottle high, 1 bottle low
LIVONGO HEALTH, INC
In Touch
In Commercial Distribution

  • 00853553005158 ()
OFG00155

  • Glucose IVD, control

In Touch Lancing Device - 00853553005141

Box of 1 Lancet Device
LIVONGO HEALTH, INC
In Touch
In Commercial Distribution

  • 00853553005141 ()
OFG00156

  • Manual blood lancing device, reusable

In Touch Blood Glucose Test Strips - 00853553005110

Box of 1 Vial of 50 In Touch Test Strips
LIVONGO HEALTH, INC
In Touch
In Commercial Distribution

  • 00853553005110 ()
OFG00154

  • Glucose IVD, reagent

In Touch Refill Kit - 00853553005103

6 boxes of In Touch Test Strips, 1 box of In Touch Lancets, 1 box of In Touch high/low Control Solution
LIVONGO HEALTH, INC
In Touch
In Commercial Distribution

  • 00853553005103 ()
KIT00147

  • Blood lancing device tip
  • Glucose IVD, control
  • Glucose IVD, reagent

In Touch Welcome Kit - 00853553005097

In Touch Blood Glucose Meter BG200, 1 In Touch Control Solution high/low, 3 boxes of In Touch Test Strips, 1 In Touch Lancing Device, 3 boxes of sterile In Touch Lancets, 1 Carrying Case, 1 Charger, 1 Charger cable, 1 Instructions for Use (English and Spanish), About Guide (English and Spanish)
LIVONGO HEALTH, INC
In Touch
In Commercial Distribution

  • 00853553005097 ()
KIT00145

  • Glucose monitoring system IVD, home-use

In Touch Sterile Lancets - 00853553005066

Box of 100 Sterile Lancets
LIVONGO HEALTH, INC
In Touch
In Commercial Distribution

  • 00853553005066 ()
OFG00142

  • Blood lancing device tip

Inb Touch Lancing Device - 00853553005059

Box of 1 Lancet Device
LIVONGO HEALTH, INC
In Touch
In Commercial Distribution

  • 00853553005059 ()
OFG00141

  • Manual blood lancing device, reusable

In Touch Glucose Control Solutions - 00853553005028

Box of High/Low Control Solution
LIVONGO HEALTH, INC
In Touch
In Commercial Distribution

  • 00853553005028 ()
OFG00140

  • Glucose IVD, control

InHealth Technologies; Blom-Singer - 00813307014744

No Description
Freudenberg Medical, LLC
IN 4066
In Commercial Distribution

  • 00813307014744 ()
  • 00848253002682 ()


  • Airway device cleaning utensil, invasive

InHealth Technologies; Blom-Singer - 00813307014737

No Description
Freudenberg Medical, LLC
IN 4065
In Commercial Distribution

  • 00813307014737 ()
  • 00848253002675 ()


  • Airway device cleaning utensil, invasive

InHealth Technologies; Blom-Singer - 00813307014720

No Description
Freudenberg Medical, LLC
IN 4064
In Commercial Distribution

  • 00813307014720 ()
  • 00848253002668 ()


  • Airway device cleaning utensil, invasive

InHealth Technologies; Blom-Singer; Classic - 00813307014577

No Description
Freudenberg Medical, LLC
IN 1612-IR
In Commercial Distribution

  • 00813307014577 ()


  • Airway device cleaning utensil, invasive
  • Tracheoesophageal speech valve, indwelling, non-sterile
  • Tracheoesophageal speech valve irrigation device
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal device introducer
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