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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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Eikon - 00816728020745

LT Retractor, 90 mm, Wide, Teeth
STRYKER CORPORATION
C90WT
In Commercial Distribution

  • 00816728020745 ()
C90WT

  • Fibreoptic retractor handle

Eikon - 00816728020721

LT Retractor, 90mm, Narrow, Teeth
STRYKER CORPORATION
C90NT
In Commercial Distribution

  • 00816728020721 ()
C90NT

  • Fibreoptic retractor handle

Eikon - 00816728020714

LT Retractor, 90mm, Narrow
STRYKER CORPORATION
C90N
In Commercial Distribution

  • 00816728020714 ()
C90N

  • Fibreoptic retractor handle

Eikon - 00816728020707

LT Retractor, 90mm
STRYKER CORPORATION
C90
In Commercial Distribution

  • 00816728020707 ()
C90

  • Fibreoptic retractor handle

Eikon - 00816728020691

LT Retractor, 50 mm, Teeth
STRYKER CORPORATION
C50T
In Commercial Distribution

  • 00816728020691 ()
C50T

  • Fibreoptic retractor handle

Eikon - 00816728020684

LT Retractor, 50 mm
STRYKER CORPORATION
C50
In Commercial Distribution

  • 00816728020684 ()
C50

  • Fibreoptic retractor handle

Eikon - 00816728020677

LT Retractor, 40mm, Narrow
STRYKER CORPORATION
C40N
In Commercial Distribution

  • 00816728020677 ()
C40N

  • Fibreoptic retractor handle

Eikon - 00816728020660

LT Retractor, 40 mm, Extra Narrow
STRYKER CORPORATION
C40XN
In Commercial Distribution

  • 00816728020660 ()
C40XN

  • Fibreoptic retractor handle

Eikon - 00816728020493

LT Retractor, A-N, 35mm & 50mm Extra Narrow
STRYKER CORPORATION
C3550ANXN
In Commercial Distribution

  • 00816728020493 ()
C3550ANXN

  • Fibreoptic retractor handle

Eikon - 00816728020486

LT Retractor, A-N, 35mm & 50mm Narrow
STRYKER CORPORATION
C3550ANN
In Commercial Distribution

  • 00816728020486 ()
C3550ANN

  • Fibreoptic retractor handle

PhotonSaber Y - 00816728020462

Y Aspirator, Bulb Tip
STRYKER CORPORATION
Bulb Tip
In Commercial Distribution

  • 00816728020462 ()
ES1Y

  • Surgical/emergency suction cannula, illuminating, single-use

PhotonSaber Y - 00816728020448

Y Aspirator, Taper Tip
STRYKER CORPORATION
Taper Tip
In Commercial Distribution

  • 00816728020448 ()
ES3Y

  • Surgical/emergency suction cannula, illuminating, single-use

PhotonSaber Y - 00816728020431

Y Aspirator, Metal Tip
STRYKER CORPORATION
Metal Tip
In Commercial Distribution

  • 00816728020431 ()
ES4Y

  • Surgical/emergency suction cannula, illuminating, single-use

PhotonSaber F - 00816728020424

F Aspirator, 12 Fr, Standard, Round
STRYKER CORPORATION
1911273
In Commercial Distribution

  • 00816728020424 ()
1911273

  • Surgical/emergency suction cannula, illuminating, single-use

PhotonSaber F - 00816728020141

F Aspirator, 8 Fr, Long, Teardrop
STRYKER CORPORATION
PSF08LT
In Commercial Distribution

  • 00816728020141 ()
PSF08LT

  • Surgical/emergency suction cannula, illuminating, single-use

PhotonSaber F - 00816728020134

F Aspirator, 8 Fr, Standard, Teardrop
STRYKER CORPORATION
PSF08ST
In Commercial Distribution

  • 00816728020134 ()
PSF08ST

  • Surgical/emergency suction cannula, illuminating, single-use

PhotonSaber F - 00816728020127

F Aspirator, 12 Fr, Long, Round
STRYKER CORPORATION
PSF12LR
In Commercial Distribution

  • 00816728020127 ()
PSF12LR

  • Surgical/emergency suction cannula, illuminating, single-use

PhotonGuide - 00816728020080

Illuminator, Wide/Flat
STRYKER CORPORATION
Wide / Flat
In Commercial Distribution

104015

  • Fibreoptic operating light system

PhotonGuide - 00816728020073

Illuminator, Narrow/Flat
STRYKER CORPORATION
Narrow / Flat
In Commercial Distribution

104008

  • Fibreoptic operating light system

NA - 07613327487558

SYSTEM 9, 2 STERILE BATTERY CONTAINER LID
STRYKER CORPORATION
9102762030
In Commercial Distribution

  • 07613327487558 ()
9102-762-030

  • Device sterilization/disinfection container, reusable

NA - 07613327487541

SYSTEM 9, 3 STERILE BATTERY CONTAINER LID
STRYKER CORPORATION
9102763030
In Commercial Distribution

  • 07613327487541 ()
9102-763-030

  • Device sterilization/disinfection container, reusable

NA - 07613327487527

SYSTEM 9, 2 STERILE BATTERY CONTAINER BASE, LARGE
STRYKER CORPORATION
9102762040
In Commercial Distribution

  • 07613327487527 ()
9102-762-040

  • Device sterilization/disinfection container, reusable

NA - 07613327487510

SYSTEM 9, 2 STERILE BATTERY CONTAINER BASE, SMALL
STRYKER CORPORATION
9102662040
In Commercial Distribution

  • 07613327487510 ()
9102-662-040

  • Device sterilization/disinfection container, reusable

Neuronaute Touchproof Adapter - 03615220004171

The Touchproof Adapter is an accessory of the Neuronaute IceCap, It's composed of a cable with sub-D25 female connector on one edge and 21 touchproof on the other edge. It will allow to connect the Neuronaute IceCap to a compatible EEG recorder through the touchproof connection.
BIOSERENITY MEDICAL DEVICES GROUP
1001-15024-US
Not in Commercial Distribution

  • 03615220004171 ()
1001-15024-US

  • Electroencephalographic electrode cap, single-use

Neuronaute Plus - Core Module - 03615220003990

No Description
BIOSERENITY MEDICAL DEVICES GROUP
1001-10006-US
Not in Commercial Distribution

  • 03615220003990 ()


  • Electroencephalographic ambulatory recorder

Neuronaute® IceCap Neonate (S) - 03615220003969

The IceCaps are medical devices used as EEG electrodes. They are used by Healthcare Professionals on a patient in case of neurological disorders with a short or long-term EEG record (up to 72 hours). IceCap 2 shall be placed on patients weighing at least 10 kg (22.05 Ibs) and having a head circumference above 43 cm (16.93 inches). IceCap Neonate shall be placed on the head of babies, newborns and premature babies.
BIOSERENITY MEDICAL DEVICES GROUP
1001-01019-UN
In Commercial Distribution

  • 03615220003969 ()


  • Electroencephalographic electrode cap, single-use

Neuronaute® IceCap Neonate (M) - 03615220003952

The IceCaps are medical devices used as EEG electrodes. They are used by Healthcare Professionals on a patient in case of neurological disorders with a short or long-term EEG record (up to 72 hours). IceCap 2 shall be placed on patients weighing at least 10 kg (22.05 Ibs) and having a head circumference above 43 cm (16.93 inches). IceCap Neonate shall be placed on the head of babies, newborns and premature babies.
BIOSERENITY MEDICAL DEVICES GROUP
1001-01018-UN
In Commercial Distribution

  • 03615220003952 ()


  • Electroencephalographic electrode cap, single-use

Neuronaute Touchproof Adapter - 03615220003846

The Touchproof Adapter is an accessory of the Neuronaute IceCap, It's composed of a cable with sub-D25 female connector on one edge and 21 touchproof on the other edge. It will allow to connect the Neuronaute IceCap to a compatible EEG recorder through the touchproof connection.
BIOSERENITY MEDICAL DEVICES GROUP
1001-15024-UN
In Commercial Distribution

  • 03615220003846 ()
1001-15024-US

  • Electroencephalographic electrode cap, single-use

Neuronaute IceCap 2 Small - 03615220003792

The IceCaps are medical devices used as EEG electrodes. They are used by Healthcare Professionals on a patient in case of neurological disorders with a short or long-term EEG record (up to 72 hours). IceCap 2 shall be placed on patients weighing at least 10 kg (22.05 Ibs) and having a head circumference above 43 cm (16.93 inches). IceCap Neonate shall be placed on the head of babies, newborns and premature babies.
BIOSERENITY MEDICAL DEVICES GROUP
1001-01015-UN
In Commercial Distribution

  • 03615220003792 ()


  • Electroencephalographic electrode cap, single-use

Neuronaute Plus Touchproof Extender - 03615220003679

No Description
BIOSERENITY MEDICAL DEVICES GROUP
1001-15023-UN
Not in Commercial Distribution

  • 03615220003679 ()


  • Electroencephalographic ambulatory recorder

Neuronaute Plus- IceCap Extender - 03615220003662

No Description
BIOSERENITY MEDICAL DEVICES GROUP
1001-15022-UN
Not in Commercial Distribution

  • 03615220003662 ()


  • Electroencephalographic ambulatory recorder

Neuronaute Plus - DB25 Extender - 03615220003655

No Description
BIOSERENITY MEDICAL DEVICES GROUP
1001-15021-UN
Not in Commercial Distribution

  • 03615220003655 ()


  • Electroencephalographic ambulatory recorder

Neuronaute - IceAdapter - 03615220003624

Neuronaute - IceAdapter is a cable that enables to plug the Neuronaute IceCap electrodes with another DB25 cable and be connected to a compatible EEG monitoring system.
BIOSERENITY MEDICAL DEVICES GROUP
1001-15020-UN
In Commercial Distribution

  • 03615220003624 ()


  • Electroencephalographic electrode cap, reusable

Neuronaute IceCap 2 - 03615220003617

The IceCaps are medical devices used as EEG electrodes. They are used by Healthcare Professionals on a patient in case of neurological disorders with a short or long-term EEG record (up to 72 hours). IceCap 2 shall be placed on patients weighing at least 10 kg (22.05 Ibs) and having a head circumference above 43 cm (16.93 inches). IceCap Neonate shall be placed on the head of babies, newborns and premature babies.
BIOSERENITY MEDICAL DEVICES GROUP
1001-01014-UN
In Commercial Distribution

  • 03615220003617 ()


  • Electroencephalographic electrode cap, single-use

Silfradent S.r.l. - 08056093310016

SURGYBONE, the electromedical equipment by SILFRADENT Srl, is a dental instrument performing operations in the field of dental piosthesis and endodontics by means of ultrasound vibrations produced by a piezoelectric transducer.
SILFRADENT SRL
SURGYBONE na
In Commercial Distribution

  • 08056093310016 ()
  • 18056093310013 ()


  • Ultrasonic dental scaling/debridement system

RePlay - 00816734023174

RePlay Hemostasis Clip, 18 mm
DIVERSATEK HEALTHCARE, INC.
1170-03
In Commercial Distribution

  • 10816734023171 ()
  • 00816734023174 ()
  • 20816734023178 ()
1170-03

  • Gastrointestinal endoscopic clip, short-term

Lasso - 00816734023051

Lasso Polypectomy Snare
DIVERSATEK HEALTHCARE, INC.
1180-15
In Commercial Distribution

  • 10816734023058 ()
  • 00816734023051 ()
  • 20816734023055 ()


  • Mechanical-cutting endoscopic polypectomy snare

Lasso - 00816734023044

Lasso Polypectomy Snare
DIVERSATEK HEALTHCARE, INC.
1180-14
In Commercial Distribution

  • 10816734023041 ()
  • 00816734023044 ()
  • 20816734023048 ()


  • Mechanical-cutting endoscopic polypectomy snare

GIJaw - 00816734021651

GIJaw Single-Use Mini Biopsy Forceps without Needle
DIVERSATEK HEALTHCARE, INC.
1190-10
In Commercial Distribution

  • 10816734021658 ()
  • 00816734021651 ()

  • Length: 160 Centimeter
  • Width: 1.8 Millimeter
1190-10

  • Flexible endoscopic biopsy forceps, single-use

GIJaw - 00816734021644

GIJaw Single-Use Biopsy Forceps with Needle
DIVERSATEK HEALTHCARE, INC.
1190-03
In Commercial Distribution

  • 10816734021641 ()
  • 00816734021644 ()

  • Length: 180 Centimeter
  • Width: 2.3 Millimeter
1190-03

  • Flexible endoscopic biopsy forceps, single-use

GIJaw - 00816734021637

GIJaw Single-Use Biopsy Forceps without Needle
DIVERSATEK HEALTHCARE, INC.
1190-02
In Commercial Distribution

  • 10816734021634 ()
  • 00816734021637 ()

  • Length: 230 Centimeter
  • Width: 2.3 Millimeter
1190-02

  • Flexible endoscopic biopsy forceps, single-use

GIJaw - 00816734021620

GIJaw Single-Use Biopsy Forceps with Needle
DIVERSATEK HEALTHCARE, INC.
1190-01
In Commercial Distribution

  • 10816734021627 ()
  • 00816734021620 ()

  • Length: 230 Centimeter
  • Width: 2.3 Millimeter
1190-01

  • Flexible endoscopic biopsy forceps, single-use

Lasso - 00816734021613

Lasso Polypectomy Snare
DIVERSATEK HEALTHCARE, INC.
1180-11
In Commercial Distribution

  • 10816734021610 ()
  • 00816734021613 ()

  • Length: 230 Centimeter
  • Width: 25 Millimeter
1180-11

  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

Lasso - 00816734021606

Lasso Polypectomy Snare
DIVERSATEK HEALTHCARE, INC.
1180-10
In Commercial Distribution

  • 10816734021603 ()
  • 00816734021606 ()

  • Width: 15 Millimeter
  • Length: 230 Centimeter
1180-10

  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

Lasso - 00816734021590

Lasso Polypectomy Snare
DIVERSATEK HEALTHCARE, INC.
1180-04
In Commercial Distribution

  • 10816734021597 ()
  • 00816734021590 ()

  • Length: 230 Centimeter
  • Width: 32 Millimeter
1180-04

  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

Lasso - 00816734021583

Lasso Polypectomy Snare
DIVERSATEK HEALTHCARE, INC.
1180-03
In Commercial Distribution

  • 00816734021583 ()
  • 10816734021580 ()

  • Width: 25 Millimeter
  • Length: 230 Centimeter
1180-03

  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

Lasso - 00816734021576

Lasso Polypectomy Snare
DIVERSATEK HEALTHCARE, INC.
1180-02
In Commercial Distribution

  • 10816734021573 ()
  • 00816734021576 ()

  • Length: 230 Centimeter
  • Width: 15 Millimeter
1180-02

  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

Lasso - 00816734021569

Lasso Polypectomy Snare
DIVERSATEK HEALTHCARE, INC.
1180-01
In Commercial Distribution

  • 10816734021566 ()
  • 00816734021569 ()

  • Width: 10 Millimeter
  • Length: 230 Centimeter
1180-01

  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

EndoGrip - 00816734021521

EndoGrip Grasping Forceps
DIVERSATEK HEALTHCARE, INC.
1177-01
In Commercial Distribution

  • 10816734021528 ()
  • 00816734021521 ()

  • Outer Diameter: 2.3 Millimeter
  • Length: 230 Centimeter
  • Width: 8.3 Millimeter
1177-01

  • Flexible endoscopic tissue manipulation forceps, single-use

RePlay - 00816734021484

RePlay Hemostasis Clip, 11mm span
DIVERSATEK HEALTHCARE, INC.
1170-01
In Commercial Distribution

  • 10816734021481 ()
  • 00816734021484 ()

  • Length: 230 Centimeter
  • Outer Diameter: 2.3 Millimeter
  • Width: 11 Millimeter
1170-01

  • Gastrointestinal endoscopic clip, short-term
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