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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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Pro-Tec IV 5 cc - 00859942006614

Leaded Glass Syringe Shield
Mirion Technologies (capintec), Inc.
007-680
In Commercial Distribution

  • 00859942006614 ()
007-680

  • Syringe radiation shield

Pro-Tec III 5 cc - 00859942006560

Tungsten Syringe Shield
Mirion Technologies (capintec), Inc.
007-736
In Commercial Distribution

  • 00859942006560 ()
007-736

  • Syringe radiation shield

Pro-Tec II 5 cc - 00859942006522

Tungsten Syringe Shield
Mirion Technologies (capintec), Inc.
007-901
In Commercial Distribution

  • 00859942006522 ()
007-901

  • Syringe radiation shield

Tenzing 5 delivery catheter - 00853799007619

Tenzing 5 delivery catheter
ROUTE 92 MEDICAL
Gen 1
In Commercial Distribution

  • 00853799007619 ()


  • Thrombectomy suction catheter
  • Vascular guide-catheter, single-use

Posifix® -5 Baseplate - 00841439100189

5BD acrylic baseplate
MEDTEC, INC.
105021
In Commercial Distribution

  • 00841439100189 ()
105021

  • Patient positioner base plate

Zirconia Clear 5 95H14 - D800ZRSF8021

Content: 1 piece Height: 14 mm
ZIRKONZAHN SRL
ZRSF8021
In Commercial Distribution

  • D800ZRSF8021 ()


  • Dental appliance fabrication material, ceramic

Prettau® Zirconia 5 - D800ZRAD0301

Content: 1 piece Height: 16 mm Highly translucent zirconia for single crowns and small bridges (fully anatomic structures or reduced structures for veneering with ceramics)
ZIRKONZAHN SRL
ZRAD0301
In Commercial Distribution

  • D800ZRAD0301 ()


  • Dental bridge, ceramic

RESPONDER 5, ENHANCED, GETWELL - 00840828156226

RESPONDER 5, ENHANCED, GETWELL
CURBELL MEDICAL PRODUCTS, INC.
4C412U-001020F
In Commercial Distribution

  • 00840828156226 ()
21386

  • Pillow speaker

RESPONDER 5, ENHANCED, GETWELL - 00840828156219

RESPONDER 5, ENHANCED, GETWELL
CURBELL MEDICAL PRODUCTS, INC.
4C410U-701033F
In Commercial Distribution

  • 00840828156219 ()
21385

  • Pillow speaker

Sealing Cap (Size 5) - 10858395006476

Sealing Caps attach to the Molar Procedure Instrument in order to properly setup the Procedure Instrument for teeth of different pulp chamber depths. The Sealing Caps include a color-coded surface to match the proper Sealing Cap to the proper Depth Gauge. Additionally, Sealing Caps feature a sealing element intended to keep air out of the root canal system and procedure fluid inside the tooth.
SONENDO, INC.
FG-001-00105
In Commercial Distribution

  • 10858395006476 ()
  • 00858395006479 ()
GW-MOL-SC05

  • Dental delivery system instrument unit, electric
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