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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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Pkit, STS Trios, GT, SG, Arm Pad - 00842430101755

Re-order number 5808 is a case of 6 kits
MIZUHO ORTHOPEDIC SYSTEMS, INC.
5808-1
In Commercial Distribution

  • 00842430101755 ()
  • 10842430101752 ()
5808

  • Surgical linen/cushion set

N Cuvette Segments for BN II - 00842768012167

The N-cuvettessegment is an consumable in the BNII system.
Siemens Healthcare Diagnostics Products GmbH
10446520
In Commercial Distribution

  • 00842768012167 ()
  • 00842768024771 ()
OVIB31

  • Nephelometry immunoassay analyser IVD

IS CAN: 1KG SODA LIME ABSORBER - SPHERASORB W/V - 05030267090341

IS CAN: 1KG SODA LIME ABSORBER - SPHERASORB W/V
Intersurgical Incorporated
2196000
In Commercial Distribution

  • 05030267090358 ()
  • 05030267090341 ()


  • Carbon dioxide absorbent

IS CAN: 1KG SODA LIME ABSORBER - LOFLOSORB G/V - 05030267100187

IS CAN: 1KG SODA LIME ABSORBER - LOFLOSORB G/V
Intersurgical Incorporated
2198000
In Commercial Distribution

  • 05030267090273 ()
  • 05030267100187 ()


  • Carbon dioxide absorbent

MSA - 00847627006011

MSA is also known as Muscle Specific Actin (MSA)
BIOCARE MEDICAL LLC
CM079B
In Commercial Distribution

  • 00847627006011 ()


  • Muscle-specific alpha/gamma actin IVD, antibody

iProven - 08719699633254

FMH-139 is a One Step HCG Urine Pregnancy Test
Sevenground Trading B.V.
FMH-139-3
In Commercial Distribution

  • 08719699633254 ()
  • 08719699633643 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

iProven - 08719699633230

FMH-139 is a One Step HCG Urine Pregnancy Test
Sevenground Trading B.V.
FMH-139-5
In Commercial Distribution

  • 08719699633230 ()
  • 08719699633636 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

Keenhealth - 08719699632714

K-NS-356-60 is a better breath Stop Snoring Nasal Strips
Sevenground Trading B.V.
K-NS-356-60
In Commercial Distribution

  • 08719699632714 ()
  • 08719699633629 ()


  • Nasal breathing aid, external

Keenhealth - 08719699632448

K-NS-356 is a better breath Stop Snoring Nasal Strips
Sevenground Trading B.V.
K-NS-356-30
In Commercial Distribution

  • 08719699632448 ()
  • 08719699633612 ()


  • Nasal breathing aid, external

iProven - 08719699630901

FMH-139 is a One Step HCG Urine Pregnancy Test
Sevenground Trading B.V.
FMH-139-5
In Commercial Distribution

  • 08719699636408 ()
  • 08719699630901 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

NeoSpoon™ - 10812594012157

NeoSpoon is intended for use as a measuring device.
Neotech Products LLC
1/8 tsp and 1/2 tsp
In Commercial Distribution

  • 00812594012150 ()
  • 10812594012157 ()
N761

  • Medicine spoon, single-use

GIOTTO IMAGE - 08033837190110

Giotto Image is a conventional film-screen x-ray mammographic device.
I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL
GIOTTO IMAGE SRA
In Commercial Distribution

  • 18033837190117 ()
  • 08033837190110 ()

  • Height: 2240 Millimeter
  • Depth: 1140 Millimeter
  • Width: 1150 Millimeter
6702

  • Stationary mammographic x-ray system, digital

GIOTTO IMAGE - 08033837190103

Giotto Image is a conventional film-screen x-ray mammographic device.
I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL
GIOTTO IMAGE M
In Commercial Distribution

  • 08033837190103 ()
  • 18033837190100 ()

  • Height: 2240 Millimeter
  • Depth: 1140 Millimeter
  • Width: 1150 Millimeter
6501

  • Stationary mammographic x-ray system, digital

Endoline PUNC - 03665039001663

The deflation needle is used to drain gastric balloons
PRINCE MEDICAL
SN4000718
In Commercial Distribution

  • 03665039001663 ()
SN4000718

  • Gastrointestinal needle catheter

PROFIX - 03596010225993

PRO CON PL TIB IS TR RT S1 30
Smith & Nephew, Inc.
71518118
In Commercial Distribution

  • 03596010225993 ()
71518118

  • Knee tibia prosthesis trial, reusable

PROFIX - 03596010225979

PRO CON PL TIB IS TR RT S1 20
Smith & Nephew, Inc.
71518116
In Commercial Distribution

  • 03596010225979 ()
71518116

  • Knee tibia prosthesis trial, reusable

PROFIX - 03596010225962

PRO CON PL TIB IS TR RT S1 18
Smith & Nephew, Inc.
71518115
In Commercial Distribution

  • 03596010225962 ()
71518115

  • Knee tibia prosthesis trial, reusable

PROFIX - 03596010225955

PRO CON PL TIB IS TR RT S1 16
Smith & Nephew, Inc.
71518114
In Commercial Distribution

  • 03596010225955 ()
71518114

  • Knee tibia prosthesis trial, reusable

PROFIX - 03596010225948

PRO CON PL TIB IS TR RT S1 14
Smith & Nephew, Inc.
71518113
In Commercial Distribution

  • 03596010225948 ()
71518113

  • Knee tibia prosthesis trial, reusable

I-Series Washers - 10841736100483

I5 Exhaust Condenser (when no vent connection is available)
SKYTRON LLC
I5-CON
In Commercial Distribution

  • 10841736100483 ()
I5-CON

  • Surgical instrument washer/disinfector (chemical/thermal)

ri-pen® violett, - 04045396200517

The Riester diagnostic light is used for ophthalmological examination.
Rudolf Riester GmbH
5078-526
In Commercial Distribution

  • 04045396200517 ()
5078-526

  • Hand-held examination/treatment light

Pack of 6 pcs. ri-pen®, violett - 04045396198562

The Riester diagnostic light is used for ophthalmological examination.
Rudolf Riester GmbH
5078
In Commercial Distribution

  • 04045396198562 ()
5078

  • Hand-held examination/treatment light

ri-pen® red - 04045396120525

The Riester diagnostic light is used for ophthalmological examination.
Rudolf Riester GmbH
5077-526
In Commercial Distribution

  • 04045396120525 ()
5077-526

  • Hand-held examination/treatment light

ri-pen® black - 04045396120464

The Riester diagnostic light is used for ophthalmological examination.
Rudolf Riester GmbH
5075-526
In Commercial Distribution

  • 04045396120464 ()
5075-526

  • Hand-held examination/treatment light

ri-pen® silver - 04045396120389

The Riester diagnostic light is used for ophthalmological examination.
Rudolf Riester GmbH
5074-526
In Commercial Distribution

  • 04045396120389 ()
5074-526

  • Hand-held examination/treatment light

ri-pen® green - 04045396120341

The Riester diagnostic light is used for ophthalmological examination.
Rudolf Riester GmbH
5072-526
In Commercial Distribution

  • 04045396120341 ()
5072-526

  • Hand-held examination/treatment light

ri-pen® blue - 04045396120310

The Riester diagnostic light is used for ophthalmological examination.
Rudolf Riester GmbH
5071-526
In Commercial Distribution

  • 04045396120310 ()
5071-526

  • Hand-held examination/treatment light

Pack of 6 pcs. ri-pen® red - 04045396007017

The Riester diagnostic light is used for ophthalmological examination.
Rudolf Riester GmbH
5077
In Commercial Distribution

  • 04045396007017 ()
5077

  • Hand-held examination/treatment light

Pack of 6 pcs. ri-pen®, black - 04045396006997

The Riester diagnostic light is used for ophthalmological examination.
Rudolf Riester GmbH
5075
In Commercial Distribution

  • 04045396006997 ()
5075

  • Hand-held examination/treatment light

Pack of 6 pcs.ri-pen® - 04045396006980

The Riester diagnostic light is used for ophthalmological examination.
Rudolf Riester GmbH
5074
In Commercial Distribution

  • 04045396006980 ()
5074

  • Hand-held examination/treatment light

Pack of 6 pcs. ri-pen® green - 04045396006966

The Riester diagnostic light is used for ophthalmological examination.
Rudolf Riester GmbH
5072
In Commercial Distribution

  • 04045396006966 ()
5072

  • Hand-held examination/treatment light

Pack of 6 pcs. ri-pen® - 04045396006959

The Riester diagnostic light is used for ophthalmological examination.
Rudolf Riester GmbH
5071
In Commercial Distribution

  • 04045396006959 ()
5071

  • Hand-held examination/treatment light

Pack of 6 pcs. ri-pen® - 04045396006942

The Riester diagnostic light is used for ophthalmological examination.
Rudolf Riester GmbH
5070
In Commercial Distribution

  • 04045396006942 ()
5070

  • Hand-held examination/treatment light

American Eagle Instruments - 00841013109980

Quick Tip Wrench is not considered a medical device.
AMERICAN EAGLE INSTRUMENTS, INC.
AEQTW
Not in Commercial Distribution

  • 00841013109980 ()


  • Manual non-rotary dental instrument handle

Nexpowder - 08800038405332

Nexpowder is used for hemostasis of nonvariceal gastrointestinal bleeding.
NEXTBIOMEDICAL CO., LTD.
NHS02
In Commercial Distribution

  • 08800038405332 ()
  • 18800038405339 ()
  • 28800038405336 ()


  • Non-organic haemostatic agent

Nexpowder - 08800038405325

Nexpowder is used for hemostasis of nonvariceal gastrointestinal bleeding.
NEXTBIOMEDICAL CO., LTD.
NHS01
In Commercial Distribution

  • 08800038405325 ()
  • 18800038405322 ()
  • 28800038405329 ()


  • Non-organic haemostatic agent

Nexpowder - 08800038405189

Nexpowder is used for hemostasis of nonvariceal gastrointestinal bleeding.
NEXTBIOMEDICAL CO., LTD.
NHS03
In Commercial Distribution

  • 18800038405186 ()
  • 08800038405189 ()
  • 28800038405183 ()


  • Non-organic haemostatic agent

GEN2 - 00840343715342

MULTI HOLE SUCTION TUBE 23CM CAP IS FIXATED / NON-REMOVABLE
SURGIX MEDICAL LLC
G2G35878
In Commercial Distribution

  • 00840343715342 ()

  • Length: 24.75 Centimeter
  • working length 10.5 cm
G2G35878

  • Suction system catheter, general-purpose

TOURNIK-IT - 08057592700025

TOURNIK-IT is a hemostasis system used to control bleeding
FLAMOR SRL
TK-00
In Commercial Distribution

  • 08057592700025 ()


  • Venous tourniquet, reusable

GIZA - 07640167930319

The GIZA is a spinal vertebral body replacement device.
Eden Spine Europe SA
Corpectomy Implant GIZA D 27 T3 4°
In Commercial Distribution

  • 07640167930319 ()
GL303000S

  • Vertebral body prosthesis
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