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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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GENESIS II ONE PIECE TIBIAL ALIGNMENT ANKLE CLAMP
Smith & Nephew, Inc.
71440438
In Commercial Distribution

  • 03596010215529 ()
71440438

  • Bone approximation clamp
Chroma Chameleon One Shade Composite 4gm. Syringe - MARK3
CARGUS INTERNATIONAL, INC
4852
In Commercial Distribution

  • D79648522 ()
  • D79648521 ()
4852

  • Dental composite resin
545CV WAFFLE CUSTOM HEEL ELEVATOR - ONE SIZE - SNGL
EHOB INC
REV00
In Commercial Distribution

  • 30603354300607 ()
  • 10603354300184 ()
5450CVXX010

  • Heel protector
545CX WAFFLE CUSTOM HEEL ELEVATOR - ONE SIZE - SNGL
EHOB INC
REV00
In Commercial Distribution

  • 30603354300454 ()
  • 10603354300122 ()
5450CXXX010

  • Heel protector
Coated Allis Bone Plate Clamp One End Coated
INNOMED, INC.
1381
In Commercial Distribution

  • 00840277117960 ()
381

  • Bone approximation clamp
SURGICAL KIT FOR PRE/KOH ONE IMPLANT SYSTEM
SWEDEN & MARTINA SPA
ZPREKOH-ONE-INT
In Commercial Distribution

  • D7701330763 ()
ZPREKOH-ONE-INT

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
GUIDED SURGERY PIVOT PREMIUM ONE, M1.80, SLEEVE 550
SWEDEN & MARTINA SPA
GS-PRN-AS-M18-550
In Commercial Distribution

  • D7701515683 ()
GS-PRN-AS-M18-550

  • Fixture/appliance dental drill bit, reusable
GUIDED SURGERY PIVOT PREMIUM ONE, M1.80, SLEEVE 415
SWEDEN & MARTINA SPA
GS-PRN-AS-M18-415
In Commercial Distribution

  • D7701515673 ()
GS-PRN-AS-M18-415

  • Fixture/appliance dental drill bit, reusable
HEEL/ELBOW PROTECTOR, Heel/Elbow Protector (One Size)
Walgreen Health Solutions, LLC
831727004114
In Commercial Distribution

  • G0648317270041140 ()
831727004114

  • Elbow/ankle friction/impact protector
ONE BOTTLE BOND Liquid Light Cure 6 ml
DARBY DENTAL SUPPLY, LLC
SDBK
In Commercial Distribution

  • 00889813001707 ()
9509082

  • Dentine adhesive
ONE Classic select Artist Collection bowl of 100.
GLOBAL PROTECTION CORP.
11000BZ
In Commercial Distribution

  • 80726893115152 ()
  • 00726893115156 ()


  • Basic male condom, Hevea-latex
ONE Classic select Contest Collection bowl of 100
GLOBAL PROTECTION CORP.
11000B
In Commercial Distribution

  • 80726893111697 ()
  • 00726893111691 ()


  • Basic male condom, Hevea-latex
OPTIGLAZE™ OPTIGLAZE Contains: One (15 mL) bottle.
Gc America Inc.
002613
In Commercial Distribution

  • 14548161282574 ()

  • Total Volume: 15 Milliliter
002613

  • Dental unfilled resin sealant/coating
DRILL BIT 6.5 AMP STERILE - BOX OF ONE
Smith & Nephew, Inc.
72202821
In Commercial Distribution

  • 00885554000405 ()
72202821

  • Cannulated surgical drill bit, single-use
DRILL BIT 2.7MM AMP ST. - BX OF ONE
Smith & Nephew, Inc.
72202818
In Commercial Distribution

  • 00885554000375 ()
72202818

  • Cannulated surgical drill bit, single-use
Bone Wax Contents: One (1) Bars 2.5 Grams
TELEFLEX INCORPORATED
IPN029172
In Commercial Distribution

  • 34026704635659 ()
  • 14026704635655 ()
  • 04026704590476 ()
BW-102

  • Bone wax, natural
Scis wire cutting 4" str one blde serr
TELEFLEX INCORPORATED
IPN017000
In Commercial Distribution

  • 54026704789240 ()
  • 14026704789242 ()
P13221

  • General-purpose surgical scissors, reusable
OxyGo (Inogen One G3 Oxygen Concentrator) (10-06327-XX-XX) (1400-1000)
Inogen, Inc.
1050
In Commercial Distribution

  • 00817131020100 ()
IO-300

  • Mobile/portable oxygen concentrator
OxyGo (Inogen One G3 Oxygen Concentrator) (10-06327-XX-XX) (1400-1000)
Inogen, Inc.
1050
In Commercial Distribution

  • 00817131020094 ()
IO-300

  • Mobile/portable oxygen concentrator
OxyGo (Inogen One G3 Oxygen Concentrator) (10-05560-XX-XX) (1400-1000)
Inogen, Inc.
840
In Commercial Distribution

  • 00817131020087 ()
IO-300

  • Mobile/portable oxygen concentrator
OxyGo (Inogen One G3 Oxygen Concentrator) (10-05560-XX-XX) (1400-1000)
Inogen, Inc.
840
In Commercial Distribution

  • 00817131020070 ()
IO-300

  • Mobile/portable oxygen concentrator
FRACTURED THREAD REMOVER (ONE PIECE/FLOATING SCREW ABUT)
JJGC Indústria e Comércio de Materiais Dentários S/A.
130.133
In Commercial Distribution

  • 07899878063551 ()

  • Length: 291.5 Millimeter
130.133

  • Surgical drill guide, single-use
One Way Stopcock with Rotating Male Luer lock
Codan US Corporation
BC111
In Commercial Distribution

  • 10813153028039 ()
  • 00813153028032 ()


  • Intravenous line stopcock
Size: 4. Contains one each of 330401 & 341004.
Boston Medical Products, Inc.
330400
In Commercial Distribution

  • 14063107100564 ()

  • Outer Diameter (Fenestrator): 6.5 mm
  • Length (Cannula): 101 mm
  • Size: 4
  • Outer Diameter (Cannula): 9 mm
330400

  • Tracheotome
  • Tracheostoma button
Size: 10. Contains one each of 331001 & 341010.
Boston Medical Products, Inc.
331000
In Commercial Distribution

  • 14063107100809 ()

  • Outer Diameter (Cannula): 13 mm
  • Size: 10
  • Length (Cannula): 101 mm
  • Outer Diameter (Fenestrator): 11 mm
331000

  • Tracheostoma button
  • Tracheotome
Size: 8. Contains one each of 330801 & 341008.
Boston Medical Products, Inc.
330800
In Commercial Distribution

  • 14063107100724 ()

  • Outer Diameter (Fenestrator): 10 mm
  • Length (Cannula): 101 mm
  • Size: 8
  • Outer Diameter (Cannula): 12 mm
330800

  • Tracheotome
  • Tracheostoma button
Size: 6. Contains one each of 330601 & 341006.
Boston Medical Products, Inc.
330600
In Commercial Distribution

  • 14063107100649 ()

  • Outer Diameter (Cannula): 11 mm
  • Size: 6
  • Length (Cannula): 101 mm
  • Outer Diameter (Fenestrator): 8 mm
330600

  • Tracheostoma button
  • Tracheotome
RALLY MV ALL IN ONE SYSTEM 70 GRAMS
Smith & Nephew, Inc.
71271685
In Commercial Distribution

  • 00885556646410 ()

  • Weight: 70 Gram
71271685

  • Orthopaedic cement preparation/delivery kit
RALLY HV ALL IN ONE SYSTEM 70 GRAMS
Smith & Nephew, Inc.
71271605
In Commercial Distribution

  • 00885556646403 ()

  • Weight: 70 Gram
71271605

  • Orthopaedic cement preparation/delivery kit
One Piece™ Slim Implant Ø3.0 X 15mm
INTRA-LOCK INTERNATIONAL, INC.
OPS3015
In Commercial Distribution

  • D742OPS30150 ()
OPS3015

  • Dental implant system
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