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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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ZOLL-DENTAL - 00840105212065

Howard #4/5
Zoll-Dental
RT-HO4/5
In Commercial Distribution

  • 00840105212065 ()


  • Dental elevator, tooth/root

ZOLL-DENTAL - 00840105211969

Heidbrink #4/5
Zoll-Dental
RT-HB4/5
In Commercial Distribution

  • 00840105211969 ()


  • Dental elevator, tooth/root

HYPE stem - 03662200020621

No Description
SOC ETUDES RECHERCHES FABRICATION
RHM607 5
In Commercial Distribution

  • 03662200020621 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

HYPE stem - 03662200020539

No Description
SOC ETUDES RECHERCHES FABRICATION
RH606 5
In Commercial Distribution

  • 03662200020539 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

HYPE stem - 03662200017881

No Description
SOC ETUDES RECHERCHES FABRICATION
COEH 5
In Commercial Distribution

  • 03662200017881 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

E-CUBE - 08800013520005

No Description
Alpinion Medical Systems Co., Ltd.
E-CUBE 5
In Commercial Distribution

  • 08800013520005 ()


  • General-purpose ultrasound imaging system

stop card - E299530050

blue
Polydentia SA
5300/5
In Commercial Distribution

  • E299530059 ()
  • E299530050 ()


  • Endodontic stopper

S5 Shelf with AC Outlet Strip - 04033817901402

No Description
LivaNova Deutschland GmbH
5 pos.
In Commercial Distribution

  • 04033817901402 ()


  • Cardiopulmonary bypass system, roller type

S5 Shelf without AC Outlet Strip - 04033817901396

No Description
LivaNova Deutschland GmbH
5 pos.
In Commercial Distribution

  • 04033817901396 ()


  • Cardiopulmonary bypass system, roller type

S&W - 10854661006461

ECG Electrodes
Leonhard Lang GmbH
FS-TF1C /5
In Commercial Distribution

  • 30854661006465 ()
  • 20854661006468 ()
  • 10854661006461 ()
  • 00854661006464 ()
540C

  • Electrocardiographic electrode, single-use

S&W - 10854661006393

ECG Electrodes
Leonhard Lang GmbH
FS-TB4 /5
In Commercial Distribution

  • 30854661006397 ()
  • 20854661006390 ()
  • 10854661006393 ()
  • 00854661006396 ()
754

  • Electrocardiographic electrode, single-use

S&W - 10854661006362

ECG Electrodes
Leonhard Lang GmbH
FS-TF1C /5
Not in Commercial Distribution

  • 30854661006366 ()
  • 20854661006369 ()
  • 10854661006362 ()
  • 00854661006365 ()
540C

  • Electrocardiographic electrode, single-use

S&W - 10854661006218

ECG Electrodes
Leonhard Lang GmbH
FS-TC1 /5
In Commercial Distribution

  • 30854661006212 ()
  • 20854661006215 ()
  • 10854661006218 ()
  • 00854661006211 ()
535

  • Electrocardiographic electrode, single-use

S&W - 10854661006164

ECG Electrodes
Leonhard Lang GmbH
FS-TF1 /5
In Commercial Distribution

  • 30854661006168 ()
  • 20854661006161 ()
  • 10854661006164 ()
  • 00854661006167 ()
540

  • Electrocardiographic electrode, single-use

S&W - 10854661006140

ECG Electrodes
Leonhard Lang GmbH
FS-RC /5
In Commercial Distribution

  • 30854661006144 ()
  • 20854661006147 ()
  • 10854661006140 ()
  • 00854661006143 ()
805

  • Electrocardiographic electrode, single-use

S&W - 10854661006102

ECG Electrodes
Leonhard Lang GmbH
CT-50 /5
In Commercial Distribution

  • 30854661006106 ()
  • 20854661006109 ()
  • 10854661006102 ()
  • 00854661006105 ()
825/S

  • Electrocardiographic electrode, single-use

EME - 10853512006193

ECG Electrodes
Leonhard Lang GmbH
FS-501 /5
In Commercial Distribution

  • 20853512006190 ()
  • 10853512006193 ()
  • 00853512006196 ()
EME2015-5S

  • Electrocardiographic electrode, single-use

Trace1 - 10853512006131

ECG Electrodes
Leonhard Lang GmbH
FS-501 /5
In Commercial Distribution

  • 30853512006135 ()
  • 20853512006138 ()
  • 10853512006131 ()
  • 00853512006134 ()
2015

  • Electrocardiographic electrode, single-use

Trace1 - 10853512006070

ECG Electrodes
Leonhard Lang GmbH
FS-OE /5
In Commercial Distribution

  • 30853512006074 ()
  • 20853512006077 ()
  • 10853512006070 ()
  • 00853512006073 ()
5550

  • Electrocardiographic electrode, single-use

Trace1 - 10853512006063

ECG Electrodes
Leonhard Lang GmbH
FS-REC /5
In Commercial Distribution

  • 30853512006067 ()
  • 20853512006060 ()
  • 10853512006063 ()
  • 00853512006066 ()
5539-5

  • Electrocardiographic electrode, single-use

Trace1 - 10853512006056

ECG Electrodes
Leonhard Lang GmbH
FS-RE /5
In Commercial Distribution

  • 30853512006050 ()
  • 20853512006053 ()
  • 10853512006056 ()
  • 00853512006059 ()
5533-5

  • Electrocardiographic electrode, single-use

Trace1 - 10853512006025

ECG Electrodes
Leonhard Lang GmbH
F-RE /5
In Commercial Distribution

  • 30853512006029 ()
  • 20853512006022 ()
  • 10853512006025 ()
  • 00853512006028 ()
5535

  • Electrocardiographic electrode, single-use

StelKast Generic Hip instruments - 10840843127789

Trial Femoral Head Assembly, 28MM -5
GLOBUS MEDICAL, INC.
SC4060-28 -5
In Commercial Distribution

  • 10840843127789 ()


  • Femoral head prosthesis trial

StelKast Generic Hip instruments - 10840843127277

Trial Femoral Head Assembly, 28 MM -5
GLOBUS MEDICAL, INC.
SC2120-28 -5
In Commercial Distribution

  • 10840843127277 ()


  • Femoral head prosthesis trial

EASYSQUEEZE - 03701430100601

No Description
LEMER PAX
5 mL
In Commercial Distribution

  • 03701430100601 ()


  • Syringe radiation shield

Easyview LE - 03701430100496

No Description
LEMER PAX
5 mL
In Commercial Distribution

  • 03701430100496 ()


  • Syringe radiation shield

Mediclic HE - 03701430100113

No Description
LEMER PAX
5 mL
In Commercial Distribution

  • 03701430100113 ()


  • Syringe radiation shield

Anodyne Surgical - 00840516127620

Irrigating Cystotome 25g X 16mm (5/8") Formed
Psi/Eye-Ko, Inc.
5003AF.5
In Commercial Distribution

  • 00840516126562 ()
  • 00840516127620 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

Anodyne Surgical - 00840516127095

Irrigating Cystotome 25g X 16mm (5/8") Formed
Psi/Eye-Ko, Inc.
5003AF.5
In Commercial Distribution

  • 00840516126562 ()
  • 00840516127095 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

American Eagle Instruments - 00841013109324

No Description
AMERICAN EAGLE INSTRUMENTS, INC.
AEOVSWV8/5
In Commercial Distribution

  • 00841013109324 ()


  • Instrument tray, reusable
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