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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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NuSmile NeoPUTTY Introductory Kit 0.5 g - SAMPLE - 00810118103780

A paste product designed for endodontic surgery or perforations, and vital pulp therapy.
NUSMILE, LTD.
SNNPIK
In Commercial Distribution

  • 00810118103780 ()

  • Weight: 0.5 Gram


  • Hygroscopic dental cement

NeoSEALER EZ-Flo (1.5 g syringe) Refill Syringe - 00810118103759

For use in obturating root canals as part of orthograde root canal therapy with gutta percha.
NUSMILE, LTD.
ANSEZFR
In Commercial Distribution

  • 00810118103759 ()

  • Weight: 2.2 Gram


  • Hygroscopic dental cement

INNO Submerged Implant System-Meta G UCLA Abutment - 08809471724246

No Description
Cowellmedi Co.,Ltd
2SGNR001N
In Commercial Distribution

  • 08809471724246 ()


  • Dental prosthesis/implant abutment screw

INNO Submerged Implant System-Meta G UCLA Abutment - 08809471724239

No Description
Cowellmedi Co.,Ltd
2SGHR001N
In Commercial Distribution

  • 08809471724239 ()


  • Dental prosthesis/implant abutment screw

Fixture Removal Guide Pins Kit Platform G - 07340152102225

Surgical Instrument Guide pin used during OPRA™ Fixture removal. Provides a guiding system to centre the Trephine aligned to the Fixture when used together with Guide Sleeve.
Integrum AB
2617
In Commercial Distribution

  • 07340152102225 ()


  • Internal-external leg prosthesis osseointegration bar

Instrument Kit: Fixture Removal PF G USA - 07340152102034

The intended purpose of the Fixture Removal kit is, by an Integrum certified physician, to perform the removal of a Femur Fixture. Consist of instruments: Mounting Tool for Trephine Guide Pins Fixture Mount Screw Fixture Mount Hammer Hammer Handle Fixture Mount Connector Fixture Mount Connector Screw Fixture Mount Handle Spanner 8 mm Spanner 12 mm Spanner 14 mm Spanner 19 mm
Integrum AB
2532
In Commercial Distribution

  • 07340152102034 ()


  • Internal-external leg prosthesis osseointegration bar

Instrument Kit: Abutment Extraction PF G USA - 07340152101976

The intended purpose is for certified surgeons, to conduct the surgical procedure for Abutment Extraction, facilitate removal of Abutment and Abutment Screw within an OPRA™ Implant System in a patient. Consist of instruments: Clamp head Clamp head Pusher Clamp head Screw Pressure Peg Hex T-Handle 5 mm Spanner 14 mm Spanner 12 mm Spanner 10 mm
Integrum AB
2531
In Commercial Distribution

  • 07340152101976 ()


  • Internal-external leg prosthesis osseointegration bar

b-ONE™ Primary Acetabular System - 00843575103543

Cementless Acetabular Shell, Cluster Hole; Porous Plasma Spray + HA Coating; 52mm Outer Diameter, Liner Size G
B-ONE ORTHO, CORP.
881311521G
In Commercial Distribution

  • 00843575103543 ()
881311521G

  • Metallic acetabulum prosthesis

ICU Medical - 00840619046477

Central Venous Catheter, Heparin Coated, 3 Lumen, 16/18/18 G, 30 cm, PMAP, Expanded Kit
ICU MEDICAL, INC.
41414-23
In Commercial Distribution

  • 10840619046474 ()
  • 00840619046477 ()
414140423

  • Centrally-inserted central venous catheter

ICU Medical - 00840619046460

Central Venous Catheter, Heparin Coated, 3 Lumen, 16/18/18 G, 30 cm, LAV, Basic Kit
ICU MEDICAL, INC.
41413-15
In Commercial Distribution

  • 10840619046467 ()
  • 00840619046460 ()
414130415

  • Centrally-inserted central venous catheter
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