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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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IPS Classic - 07615208406047

IPS Gingiva Opaquer 3 g rosa
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
546676
In Commercial Distribution

  • 07615208450316 ()
  • 07615208406047 ()
  • DIVO5466761 ()
546676

  • Dental appliance fabrication material, ceramic

ProBase Hot / ProBase Cold - 07615208401400

ProBase Cold Polymer 2x500 g preference
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
563542
In Commercial Distribution

  • 07615208433340 ()
  • 07615208401400 ()
  • DIVO5635421 ()
563542

  • Dental appliance fabrication material, resin

PFT Kit G, VBMax36E - 00817081022254

Pulmonary Function Testing Kit G, VBMax36E
A-M SYSTEMS, LLC
PFT Kit G, VBMax36E - 189156
In Commercial Distribution

  • 00817081022261 ()
  • 00817081022254 ()
189156

  • Pulmonary function testing kit

Surgical Direct - B382SD914546450

10 1/2 Mallet, 450 g
Surgical Direct, Inc.
SD91454645
In Commercial Distribution

  • B382SD914546450 ()
SD91454645

  • Surgical mallet

Surgical Direct - B382SD914545200

7 inch Partsch Mallet, 200 g
Surgical Direct, Inc.
SD91454520
In Commercial Distribution

  • B382SD914545200 ()
SD91454520

  • Surgical mallet

Mpact DM Converter - 07630030812330

Double Mobility Converter Liner G/DMF
Medacta International SA
01.32.4452MC
In Commercial Distribution

  • 07630030812330 ()


  • Metallic acetabular liner

Mpact Acetabular System - 07630030812002

Flat PE liner Ø 32 / G
Medacta International SA
01.32.3252STT
In Commercial Distribution

  • 07630030812002 ()


  • Non-constrained polyethylene acetabular liner

DM Converter – TiN coated - 07630971256378

DM Converter G/DMF - TiN coated
Medacta International SA
01.32.4452CF
In Commercial Distribution

  • 07630971256378 ()


  • Metallic acetabular liner

PFT Kit G, VBMax28E - 00817081022216

Pulmonary Function Testing Kit G, VBMax28E
A-M SYSTEMS, LLC
PFT Kit G, VBMax28E - 189178
In Commercial Distribution

  • 00817081022223 ()
  • 00817081022216 ()
189178

  • Pulmonary function testing kit

PFT Kit G, VBMax35E - 00817081022193

Pulmonary Function Testing Kit G, VBMax35E
A-M SYSTEMS, LLC
PFT Kit G, VBMax35E - 189155
In Commercial Distribution

  • 00817081022209 ()
  • 00817081022193 ()
189155

  • Pulmonary function testing kit

MEDI-VAC - 10630140153143

G Ring 1L Reg W/Tab
Cardinal Health 200, LLC
65652-143
In Commercial Distribution

  • 10630140153143 ()
65652-143

  • Suction/irrigation system canister/bottle holder, reusable

Dalbo®-PLUS - 07640166514923

Dalbo®-PLUS Duplicating aid G
Cendres+Métaux SA
072626
In Commercial Distribution

  • 07640166514923 ()
072626

  • Dental precision attachment simulator/analog, single-use

MEDI-VAC - 10630140153174

G 1L Ring CTW W/Tab
Cardinal Health 200, LLC
65652-148
In Commercial Distribution

  • 10630140153174 ()
65652-148

  • Suction/irrigation system canister/bottle holder, reusable

Vision-Zirkon - EWOH24931

Vision-Zirkon Shade guide Shoulder/OD/G
WOHLWEND AG DENTAL MANUFAKTUR
2493
In Commercial Distribution

  • EWOH24931 ()
2493

  • Dental appliance fabrication material, ceramic

BIOSTOP - 10603295174738

BIOSTOP G CEMENT RESTRICTOR STERILIZATION CASE
DEPUY ORTHOPAEDICS, INC.
5463-62-500
Not in Commercial Distribution

  • 10603295174738 ()
546362500

  • Instrument tray, reusable

BIOSTOP - 10603295174684

BIOSTOP G CEMENT RESTRICTOR HOLDER 8mm
DEPUY ORTHOPAEDICS, INC.
5463-48-500
Not in Commercial Distribution

  • 10603295174684 ()
546348500

  • Surgical implant/trial-implant/sizer holder, reusable

BIOSTOP - 10603295174677

BIOSTOP G CEMENT RESTRICTOR TRIAL 20mm
DEPUY ORTHOPAEDICS, INC.
5463-40-500
Not in Commercial Distribution

  • 10603295174677 ()
546340500

  • Orthopaedic prosthesis implantation positioning instrument, reusable

BIOSTOP - 10603295174660

BIOSTOP G CEMENT RESTRICTOR TRIAL 18mm
DEPUY ORTHOPAEDICS, INC.
5463-38-500
Not in Commercial Distribution

  • 10603295174660 ()
546338500

  • Orthopaedic prosthesis implantation positioning instrument, reusable

BIOSTOP - 10603295174653

BIOSTOP G CEMENT RESTRICTOR TRIAL 16mm
DEPUY ORTHOPAEDICS, INC.
5463-36-500
Not in Commercial Distribution

  • 10603295174653 ()
546336500

  • Orthopaedic prosthesis implantation positioning instrument, reusable

BIOSTOP - 10603295174646

BIOSTOP G CEMENT RESTRICTOR TRIAL 14mm
DEPUY ORTHOPAEDICS, INC.
5463-34-500
Not in Commercial Distribution

  • 10603295174646 ()
546334500

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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