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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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Creation Willi Geller - ECWG0015411

CC/ Opaque Dentine OD-41 (D3)
KLEMA Dentalprodukte GmbH
001541
In Commercial Distribution

  • ECWG0015411 ()
001541

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0015371

CC/ Opaque Dentine OD-37 (B4)
KLEMA Dentalprodukte GmbH
001537
In Commercial Distribution

  • ECWG0015371 ()
001537

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0015321

CC/ Opaque Dentine OD-32 (A2-A3)
KLEMA Dentalprodukte GmbH
001532
In Commercial Distribution

  • ECWG0015321 ()
001532

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0015271

CC/ Shoulder SP-27 ivory 15g
KLEMA Dentalprodukte GmbH
001527
In Commercial Distribution

  • ECWG0015271 ()
001527

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0015241

CC/ Shoulder SP-24 gold 15g
KLEMA Dentalprodukte GmbH
001524
In Commercial Distribution

  • ECWG0015241 ()
001524

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0005831

CC/ Pearl Enamel PS-2 flamingo
KLEMA Dentalprodukte GmbH
000583
In Commercial Distribution

  • ECWG0005831 ()
000583

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0005811

CC/ Pearl Enamel PS-0 white
KLEMA Dentalprodukte GmbH
000581
In Commercial Distribution

  • ECWG0005811 ()
000581

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0002811

CC/ Pearl Enamel PS-0 white
KLEMA Dentalprodukte GmbH
000281
In Commercial Distribution

  • ECWG0002811 ()
000281

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - ECWG0002561

CC/ Bleach Shoulder SP-AB 15g
KLEMA Dentalprodukte GmbH
000256
In Commercial Distribution

  • ECWG0002561 ()
000256

  • Dental appliance fabrication material, ceramic

AoN Implants - 00840192701565

2 pieces Transfer - Short - CC
FAICO MEDICAL LLC
ATR00SHOSN00C
Not in Commercial Distribution

  • 00840192701565 ()


  • Dental implant system

AoN Implants - 00840192701558

2 pieces Transfer - Long - CC
FAICO MEDICAL LLC
ATR00LNGSN00C
Not in Commercial Distribution

  • 00840192701558 ()


  • Dental implant system

AoN Implants - 00840192701527

Transfer - h.9 mm. - CC
FAICO MEDICAL LLC
ATR00SHOIP00C
Not in Commercial Distribution

  • 00840192701527 ()


  • Dental implant system

AoN Implants - 00840192701510

Transfer - h.12 mm. - CC
FAICO MEDICAL LLC
ATR00000IP00C
Not in Commercial Distribution

  • 00840192701510 ()


  • Dental implant system

AoN Implants - 00840192717016

OverDLock - h.6 mm. - CC
FAICO MEDICAL LLC
ALK000600000C
Not in Commercial Distribution

  • 00840192717016 ()


  • Dental implant system

AoN Implants - 00840192717009

OverDLock - h.5 mm. - CC
FAICO MEDICAL LLC
ALK000500000C
Not in Commercial Distribution

  • 00840192717009 ()


  • Dental implant system

AoN Implants - 00840192716996

OverDLock - h.4 mm. - CC
FAICO MEDICAL LLC
ALK000400000C
Not in Commercial Distribution

  • 00840192716996 ()


  • Dental implant system

AoN Implants - 00840192716989

OverDLock - h.3 mm. - CC
FAICO MEDICAL LLC
ALK000300000C
Not in Commercial Distribution

  • 00840192716989 ()


  • Dental implant system

AoN Implants - 00840192716972

OverDLock - h.2 mm. - CC
FAICO MEDICAL LLC
ALK000200000C
Not in Commercial Distribution

  • 00840192716972 ()


  • Dental implant system

AoN Implants - 00840192716965

OverDLock - h.1 mm. - CC
FAICO MEDICAL LLC
ALK000100000C
Not in Commercial Distribution

  • 00840192716965 ()


  • Dental implant system

General Instruments - 00840180537251

INSIGNIA CC DS GUIDE, SP
ALPHATEC SPINE, INC.
CI-11783-CC15
In Commercial Distribution

  • 00840180537251 ()


  • Surgical drill guide, reusable

General Instruments - 00840180536407

INSIGNIA CC VA DS GUIDE
ALPHATEC SPINE, INC.
CI-11753-CC
In Commercial Distribution

  • 00840180536407 ()


  • Surgical drill guide, reusable

General Instrument - 00840180511718

Modular OCT Screw Tip, CC
ALPHATEC SPINE, INC.
CI-11087-CC
In Commercial Distribution

  • 00840180511718 ()


  • Surgical implant handling forceps

Inertia® CONNEXX™ Modular Pedicle Screw System - 00889929048146

Sterile Cann CC Shank, Ø8.5x40mm
NEXXT SPINE, LLC
20-SCC-8540-SP
In Commercial Distribution

  • 00889929048146 ()

  • Outer Diameter: 8.5 Millimeter
  • Length: 40 Millimeter


  • Spinal bone screw, non-bioabsorbable

Inertia® CONNEXX™ Modular Pedicle Screw System - 00889929048122

Sterile Cann CC Shank, Ø7.0x25mm
NEXXT SPINE, LLC
20-SCC-7025-SP
In Commercial Distribution

  • 00889929048122 ()

  • Outer Diameter: 7.0 Millimeter
  • Length: 25 Millimeter


  • Spinal bone screw, non-bioabsorbable

Inertia® CONNEXX™ Modular Pedicle Screw System - 00889929048108

Sterile Cann CC Shank, Ø6.0x25mm
NEXXT SPINE, LLC
20-SCC-6025-SP
In Commercial Distribution

  • 00889929048108 ()

  • Outer Diameter: 6.0 Millimeter
  • Length: 25 Millimeter


  • Spinal bone screw, non-bioabsorbable

Inertia® CONNEXX™ Modular Pedicle Screw System - 00889929048085

Sterile Cann CC Shank, Ø5.0x25mm
NEXXT SPINE, LLC
20-SCC-5025-SP
In Commercial Distribution

  • 00889929048085 ()

  • Outer Diameter: 5.0 Millimeter
  • Length: 25 Millimeter


  • Spinal bone screw, non-bioabsorbable

I/C Graft Chamber ® - 00889858395519

IC Graft Chamber - 15 cc
LIFENET HEALTH
GDS015T
In Commercial Distribution

  • 00889858395519 ()

  • LARGE/15 cc
GDS015T

  • Bone graft syringe, single-use

I/C Graft Chamber ® - 00889858395472

IC Graft Chamber - 10 cc
LIFENET HEALTH
GDS010T
In Commercial Distribution

  • 00889858395472 ()

  • MEDIUM/10 cc
GDS010T

  • Bone graft syringe, single-use

I/C Graft Chamber ® - 00889858395434

IC Graft Chamber - 5 cc
LIFENET HEALTH
GDS005T
In Commercial Distribution

  • 00889858395434 ()

  • SMALL/5 cc
GDS005T

  • Bone graft syringe, single-use

Optium® - 00889858625708

Optium DBM Gel, 3 cc
LIFENET HEALTH
TGEL03
In Commercial Distribution

  • 00889858625708 ()

  • 3 cc
TGEL03

  • Bone matrix implant, human-derived

Darby Dental Supply, LLC - 00889813040928

FILES HED CC 25MM #8
DARBY DENTAL SUPPLY, LLC
9512440
In Commercial Distribution

  • 00889813040911 ()
  • 00889813040928 ()
9512440

  • Manual endodontic file/rasp, single-use

Darby Dental Supply, LLC - 00889813040904

FILES HED CC 21MM #8
DARBY DENTAL SUPPLY, LLC
9512417
In Commercial Distribution

  • 00889813040898 ()
  • 00889813040904 ()
9512417

  • Manual endodontic file/rasp, single-use

QLRAD - 08719326258201

RectalPro75 with 100 cc Syringe
QLRAD INTERNATIONAL LTD
105.1014
In Commercial Distribution

  • 08719326258218 ()
  • 08719326258201 ()
  • 08719326258225 ()
  • 08719326258232 ()
  • 08719326258249 ()


  • Prostate immobilization balloon catheter

Cortera Spinal Fixation System - 00840311221578

Screw, Poly, CC Solid, 9.5x60
Xtant Medical Holdings, Inc.
150101-95060
In Commercial Distribution

  • 00840311221578 ()


  • Spinal bone screw, non-bioabsorbable

Cortera Spinal Fixation System - 00840311221561

Screw, Poly, CC Solid, 9.5x55
Xtant Medical Holdings, Inc.
150101-95055
In Commercial Distribution

  • 00840311221561 ()


  • Spinal bone screw, non-bioabsorbable

Cortera Spinal Fixation System - 00840311221554

Screw, Poly, CC Solid, 9.5x50
Xtant Medical Holdings, Inc.
150101-95050
In Commercial Distribution

  • 00840311221554 ()


  • Spinal bone screw, non-bioabsorbable

Cortera Spinal Fixation System - 00840311221547

Screw, Poly, CC Solid, 9.5x45
Xtant Medical Holdings, Inc.
150101-95045
In Commercial Distribution

  • 00840311221547 ()


  • Spinal bone screw, non-bioabsorbable

Cortera Spinal Fixation System - 00840311221530

Screw, Poly, CC Solid, 9.5x40
Xtant Medical Holdings, Inc.
150101-95040
In Commercial Distribution

  • 00840311221530 ()


  • Spinal bone screw, non-bioabsorbable

Cortera Spinal Fixation System - 00840311221523

Screw, Poly, CC Solid, 9.5x35
Xtant Medical Holdings, Inc.
150101-95035
In Commercial Distribution

  • 00840311221523 ()


  • Spinal bone screw, non-bioabsorbable

Cortera Spinal Fixation System - 00840311221516

Screw, Poly, CC Solid, 9.5x30
Xtant Medical Holdings, Inc.
150101-95030
In Commercial Distribution

  • 00840311221516 ()


  • Spinal bone screw, non-bioabsorbable

Cortera Spinal Fixation System - 00840311221509

Screw, Poly, CC Solid, 9.5x25
Xtant Medical Holdings, Inc.
150101-95025
In Commercial Distribution

  • 00840311221509 ()


  • Spinal bone screw, non-bioabsorbable

Cortera Spinal Fixation System - 00840311221493

Screw, Poly, CC Solid, 9.0x60
Xtant Medical Holdings, Inc.
150101-90060
In Commercial Distribution

  • 00840311221493 ()


  • Spinal bone screw, non-bioabsorbable

Cortera Spinal Fixation System - 00840311221486

Screw, Poly, CC Solid, 9.0x55
Xtant Medical Holdings, Inc.
150101-90055
In Commercial Distribution

  • 00840311221486 ()


  • Spinal bone screw, non-bioabsorbable

Cortera Spinal Fixation System - 00840311221479

Screw, Poly, CC Solid, 9.0x50
Xtant Medical Holdings, Inc.
150101-90050
In Commercial Distribution

  • 00840311221479 ()


  • Spinal bone screw, non-bioabsorbable

Cortera Spinal Fixation System - 00840311221462

Screw, Poly, CC Solid, 9.0x45
Xtant Medical Holdings, Inc.
150101-90045
In Commercial Distribution

  • 00840311221462 ()


  • Spinal bone screw, non-bioabsorbable

Cortera Spinal Fixation System - 00840311221455

Screw, Poly, CC Solid, 9.0x40
Xtant Medical Holdings, Inc.
150101-90040
In Commercial Distribution

  • 00840311221455 ()


  • Spinal bone screw, non-bioabsorbable

Cortera Spinal Fixation System - 00840311221448

Screw, Poly, CC Solid, 9.0x35
Xtant Medical Holdings, Inc.
150101-90035
In Commercial Distribution

  • 00840311221448 ()


  • Spinal bone screw, non-bioabsorbable

Cortera Spinal Fixation System - 00840311221431

Screw, Poly, CC Solid, 9.0x30
Xtant Medical Holdings, Inc.
150101-90030
In Commercial Distribution

  • 00840311221431 ()


  • Spinal bone screw, non-bioabsorbable

Cortera Spinal Fixation System - 00840311221424

Screw, Poly, CC Solid, 9.0x25
Xtant Medical Holdings, Inc.
150101-90025
In Commercial Distribution

  • 00840311221424 ()


  • Spinal bone screw, non-bioabsorbable

Cortera Spinal Fixation System - 00840311221417

Screw, Poly, CC Solid, 8.5x60
Xtant Medical Holdings, Inc.
150101-85060
In Commercial Distribution

  • 00840311221417 ()


  • Spinal bone screw, non-bioabsorbable
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