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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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XiVE® - 07392532212147

XiVE® TG plus Implant D3.4/L13
Dentsply Implants Manufacturing GmbH
32252433
Not in Commercial Distribution

25-2433

  • Screw endosteal dental implant, one-piece

XiVE® - 07392532212130

XiVE® TG plus Implant D3.4/L11
Dentsply Implants Manufacturing GmbH
32252432
Not in Commercial Distribution

25-2432

  • Screw endosteal dental implant, one-piece

XiVE® - 07392532212123

XiVE® TG plus Implant D3.4/L9.5
Dentsply Implants Manufacturing GmbH
32252431
Not in Commercial Distribution

25-2431

  • Screw endosteal dental implant, one-piece

XiVE® - 07392532212246

XiVE® TG plus Implant D4.5/L13
Dentsply Implants Manufacturing GmbH
32252453
Not in Commercial Distribution

25-2453

  • Screw endosteal dental implant, one-piece

XiVE® - 07392532212222

XiVE® TG plus Implant D4.5/L9.5
Dentsply Implants Manufacturing GmbH
32252451
Not in Commercial Distribution

25-2451

  • Screw endosteal dental implant, one-piece

Vial Adapter - 07290108240092

Vial Adapter 20mm FLL SIL TG - VF
WEST PHARMA. SERVICES IL, . LTD
8072036
In Commercial Distribution

  • 27290108240096 ()
  • 17290108240099 ()
  • 07290108240092 ()


  • Vial/bottle adaptor, non-hermetic

XiVE® - 07392532223297

XiVE® TG Abutment angled D3.4-4.5/A15
Dentsply Implants Manufacturing GmbH
32254510
Not in Commercial Distribution

25-4510

  • Dental implant suprastructure, permanent, preformed

XiVE® - 07392532223280

XiVE® TG Abutment straight D3.4-4.5/A0
Dentsply Implants Manufacturing GmbH
32254500
In Commercial Distribution

25-4500

  • Dental implant suprastructure, permanent, preformed

XiVE® - 07392532223235

XiVE® TG Cast-to Waxing Sleeve D3.4-4.5
Dentsply Implants Manufacturing GmbH
32254246
Not in Commercial Distribution

25-4246

  • Dental implant suprastructure, permanent, preformed

XiVE® - 07392532223105

XiVE® TG Cover Screw for Implants
Dentsply Implants Manufacturing GmbH
32251400
Not in Commercial Distribution

25-1400

  • Dental implant suprastructure, temporary, preformed, single-use

MANI Sutures Silk - 04546951500160

No Description
MANI, INC.
24
In Commercial Distribution

  • 04546951500160 ()
  • 14546951500167 ()
24

  • Silk suture

Royal Purple Polymer - D85124

Tinted Powder
JBC and Company
24
In Commercial Distribution

  • D85124 ()
24

  • Dental appliance fabrication material, resin

Palmero Healthcare, LLC - 00840415107860

PROTECTALL APRON
Palmero Healthcare LLC
24
In Commercial Distribution

  • 00840415107860 ()
24

  • Radiation shielding apron

3M™ ESPE™ - 30605861025516

3M™ ESPE™ Adult Anterior Polycarbonate Replacement Crown, Upper Right Laterals, Size 24, 24
3M COMPANY
24
In Commercial Distribution

  • 50605861025510 ()
  • 30605861025516 ()
  • 00605861022576 ()
24

  • Preformed dental crown, temporary

Boekel Floor Standing Platelet Incubator Agitator - 00863626000294

Chamber that maintains 22 degrees C with constant agitation motion for the storage of Platelets.
BOEKEL INDUSTRIES, INC.
FS100
In Commercial Distribution

  • 00863626000294 ()
FS100

  • Platelet incubator

Boekel Large Platelet Incubator - 00863626000249

No Description
BOEKEL INDUSTRIES, INC.
301650
In Commercial Distribution

  • 00863626000249 ()


  • Platelet incubator

Boekel Small Platelet Incubator - 00863626000232

No Description
BOEKEL INDUSTRIES, INC.
301550
In Commercial Distribution

  • 00863626000232 ()


  • Platelet incubator

Helmer - 00816394020964

Platelet Incubator
HELMER, INC.
PC1200-Pro
In Commercial Distribution

  • 00816394020964 ()


  • Platelet incubator

Helmer - 00816394020957

Platelet Incubator
HELMER, INC.
PC900-Pro
In Commercial Distribution

  • 00816394020957 ()


  • Platelet incubator

Helmer - 00816394020940

Platelet Incubator
HELMER, INC.
PC100-Pro
In Commercial Distribution

  • 00816394020940 ()


  • Platelet incubator

i.Series® - 00816394020780

Platelet Incubator
HELMER, INC.
PC4200i
In Commercial Distribution

  • 00816394020780 ()


  • Platelet incubator

i.Series® - 00816394020773

Platelet Incubator
HELMER, INC.
PC3200i
In Commercial Distribution

  • 00816394020773 ()


  • Platelet incubator

i.Series® - 00816394020766

Platelet Incubator
HELMER, INC.
PC2200i
In Commercial Distribution

  • 00816394020766 ()


  • Platelet incubator

i.Series® - 00816394020759

Platelet Incubator
HELMER, INC.
PC1200i
Not in Commercial Distribution

  • 00816394020759 ()


  • Platelet incubator

i.Series® - 00816394020742

Platelet Incubator
HELMER, INC.
PC900i
Not in Commercial Distribution

  • 00816394020742 ()


  • Platelet incubator

i.Series® - 00816394020735

Platelet Incubator
HELMER, INC.
PC100i
Not in Commercial Distribution

  • 00816394020735 ()


  • Platelet incubator

Horizon Series™ - 00816394020728

Platelet Incubator
HELMER, INC.
PC4200h
In Commercial Distribution

  • 00816394020728 ()


  • Platelet incubator

Horizon Series™ - 00816394020711

Platelet Incubator
HELMER, INC.
PC3200h
In Commercial Distribution

  • 00816394020711 ()


  • Platelet incubator

Horizon Series™ - 00816394020704

Platelet Incubator
HELMER, INC.
PC2200h
In Commercial Distribution

  • 00816394020704 ()


  • Platelet incubator

Horizon Series™ - 00816394020698

Platelet Incubator
HELMER, INC.
PC1200h
Not in Commercial Distribution

  • 00816394020698 ()


  • Platelet incubator

Horizon Series™ - 00816394020681

Platelet Incubator
HELMER, INC.
PC900h
Not in Commercial Distribution

  • 00816394020681 ()


  • Platelet incubator

Horizon Series™ - 00816394020674

Platelet Incubator
HELMER, INC.
PC100h
Not in Commercial Distribution

  • 00816394020674 ()


  • Platelet incubator

Helmer - 00816394021688

Environmental chamber for storage of platelet concentrate
HELMER, INC.
PC2200-Pro
In Commercial Distribution

  • 00816394021688 ()


  • Platelet incubator

Helmer - 00816394021671

Environmental chamber for storage of platelet concentrate
HELMER, INC.
PC3200-PRO
In Commercial Distribution

  • 00816394021671 ()


  • Platelet incubator

Helmer - 00816394021664

Environmentatal chamber for storage of platelet concentrate
HELMER, INC.
PC4200-Pro
In Commercial Distribution

  • 00816394021664 ()


  • Platelet incubator

Power Dental USA - D9432001T00

SURGICAL CHISELS 13K/TG TITANIUM 3.5 / 3 mm
Power Dental U.S.A. Inc.
2001T
In Commercial Distribution

  • D9432001T00 ()
2001T

  • Dressing/utility forceps, scissors-like, reusable
  • Periodontal hoe

MEDI - 00636257156186

TG 8MM 3# FOAM CONDYLAR BK/BK HOOK
MEDI MANUFACTURING, INC.
201561
In Commercial Distribution

  • 00636257156186 ()


  • Knee support orthosis

ADVIA Centaur® aTG MCM - 00630414580722

TG Ab Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10492692
In Commercial Distribution

  • 00630414580722 ()
10492692

  • Thyroglobulin antibody IVD, control

TITAN IMPLANTS, INC. - 00842448112347

Titan Design 4.8mm Tg Hex Abutment Analog Aluminum
TITAN IMPLANT INC
TN-48TGHAA-AL
In Commercial Distribution

  • 00842448112347 ()


  • Dental implant abutment analog, laboratory

XiVE® - EFRI322596002

XiVE® TG Lab Set Gold Bar Coping
Dentsply Implants Manufacturing GmbH
32259600
Not in Commercial Distribution

  • EFRI322596002 ()
25-9600

  • Dental implant suprastructure kit

XiVE® - EFRI322593012

XiVE® TG Lab Set Soldering Analog Bar
Dentsply Implants Manufacturing GmbH
32259301
Not in Commercial Distribution

  • EFRI322593012 ()
25-9301

  • Dental implant suprastructure kit

XiVE® - EFRI322593002

XiVE® TG Lab Set Soldering Analog Bridge
Dentsply Implants Manufacturing GmbH
32259300
Not in Commercial Distribution

  • EFRI322593002 ()
25-9300

  • Dental implant suprastructure kit

XiVE® - EFRI322541062

XiVE® TG Lab Set Soldering Analog Bar
Dentsply Implants Manufacturing GmbH
32254106
Not in Commercial Distribution

  • EFRI322541062 ()
25-4106

  • Dental implant suprastructure kit

XiVE® - EFRI322541052

XiVE® TG Lab Set Soldering Analog Bridge
Dentsply Implants Manufacturing GmbH
32254105
Not in Commercial Distribution

  • EFRI322541052 ()
25-4105

  • Dental implant suprastructure kit

T-CONNECT FOR SINGLE - D7701023833

T-CONNECT FOR SINGLE CROWN PRE/KOH TG W
SWEDEN & MARTINA SPA
A-TG-BASTZR-S-W
In Commercial Distribution

  • D7701023833 ()
A-TG-BASTZR-S-W

  • Dental implant suprastructure, permanent, preformed

T-CONNECT FOR SINGLE - D7701002123

T-CONNECT FOR SINGLE CROWN PRE/KOH TG M
SWEDEN & MARTINA SPA
A-TG-BASTZR-S-M
In Commercial Distribution

  • D7701002123 ()
A-TG-BASTZR-S-M

  • Dental implant suprastructure, permanent, preformed

TRANSFER ECHO FOR PRE-KOH TG - D7700887003

TRANSFER ECHO FOR PRE-KOH TG IMPLANTS, WIDE PLATFORM
SWEDEN & MARTINA SPA
A-TG-CAMTRA-W
In Commercial Distribution

  • D7700887003 ()
A-TG-CAMTRA-W

  • Dental implant/prosthesis surgical procedure kit

TRANSFER ECHO FOR PRE-KOH TG - D7700886993

TRANSFER ECHO FOR PRE-KOH TG IMPLANTS, MEDIUM PLATFORM
SWEDEN & MARTINA SPA
A-TG-CAMTRA-M
In Commercial Distribution

  • D7700886993 ()
A-TG-CAMTRA-M

  • Dental implant/prosthesis surgical procedure kit

SCREW M2 FOR RIP.ABUTMENT - D7700884153

SCREW M2 FOR RIP.ABUTMENT PRE-KOH TG, WIDE, MAGENTA
SWEDEN & MARTINA SPA
A-TG-VABUR-W
In Commercial Distribution

  • D7700884153 ()
A-TG-VABUR-W

  • Dental implant suprastructure, permanent, preformed

SCREW M1.8 FOR RIP.ABUTMENT - D7700884143

SCREW M1.8 FOR RIP.ABUTMENT PRE-KOH TG, MEDIUM, GREEN
SWEDEN & MARTINA SPA
A-TG-VABUR-M
In Commercial Distribution

  • D7700884143 ()
A-TG-VABUR-M

  • Dental implant suprastructure, permanent, preformed
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