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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BITE REGISTRATION TRAYS 35/BX ANTERIOR
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
BRTA
In Commercial Distribution

  • 00817169023876 ()
BRTA

  • Dental impression tray, single-use
TRIAL, INSERT 35 X 11MM EPIK
Encore Medical, L.P.
801-03-045
In Commercial Distribution

  • 00888912133418 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
TRIAL, INSERT 35 X 10MM EPIK
Encore Medical, L.P.
801-03-044
In Commercial Distribution

  • 00888912133401 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
TRIAL, INSERT 35 X 9MM EPIK
Encore Medical, L.P.
801-03-043
In Commercial Distribution

  • 00888912133395 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
LO-PRO SCRW,TI,4.5X 35 MMCANN
ARTHREX, INC.
AR-8945-35FT
In Commercial Distribution

  • 00888867053588 ()
  • M150AR894535FT0 ()
AR-8945-35FT

  • Orthopaedic bone screw (non-sliding)
28MM BASEPLATE, 35° HALF AUG, ST
ARTHREX, INC.
AR-9581-2835S
In Commercial Distribution

  • 00888867352193 ()
AR-9581-2835S

  • Reverse shoulder prosthesis base plate
24MM BASEPLATE, 35° HALF AUG, ST
ARTHREX, INC.
AR-9581-2435S
In Commercial Distribution

  • 00888867352094 ()
AR-9581-2435S

  • Reverse shoulder prosthesis base plate
Modular Drill, 20° Full, 35 mm
ARTHREX, INC.
AR-9596-2035F
In Commercial Distribution

  • 00888867346178 ()
AR-9596-2035F

  • Cannulated surgical drill bit, reusable
Modular Drill, 10° Full, 35 mm
ARTHREX, INC.
AR-9596-1035F
In Commercial Distribution

  • 00888867346123 ()
AR-9596-1035F

  • Cannulated surgical drill bit, reusable
28MM BASEPLATE, 35° HALF AUGMENT TRIAL
ARTHREX, INC.
AR-9593-2835
In Commercial Distribution

  • 00888867343795 ()
AR-9593-2835

  • Shoulder glenoid fossa prosthesis trial
24MM BASEPLATE, 35° HALF AUGMENT TRIAL
ARTHREX, INC.
AR-9593-2435
In Commercial Distribution

  • 00888867343764 ()
AR-9593-2435

  • Shoulder glenoid fossa prosthesis trial
28MM BASEPLATE, 35° HALF AUGMENT SIZER
ARTHREX, INC.
AR-9591-2835
In Commercial Distribution

  • 00888867343696 ()
AR-9591-2835

  • Glenoid defect sizer
24MM BASEPLATE, 35° HALF AUGMENT SIZER
ARTHREX, INC.
AR-9591-2435
In Commercial Distribution

  • 00888867343665 ()
AR-9591-2435

  • Glenoid defect sizer
28MM BASEPLATE, 35° HALF AUG, OB
ARTHREX, INC.
AR-9581-2835
In Commercial Distribution

  • 00888867341777 ()
AR-9581-2835

  • Reverse shoulder prosthesis base plate
24MM BASEPLATE, 35° HALF AUG, OB
ARTHREX, INC.
AR-9581-2435
In Commercial Distribution

  • 00888867341678 ()
AR-9581-2435

  • Reverse shoulder prosthesis base plate
G2 Anterior Cervical Plate 35 mm
Neoortho Produtos Ortopédicos S/A.
942.605
Not in Commercial Distribution

  • 07898624867634 ()


  • Spinal fixation plate, non-bioabsorbable
BITE REGISTRATION TRAYS 35/BX QUADRANT
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
BRTQ
In Commercial Distribution

  • 00817169023906 ()
BRTQ

  • Dental impression tray, single-use
JACQUETTE SCLR OCT DE #34/35
SKLAR CORPORATION
49-2845
In Commercial Distribution

  • 10649111118982 ()


  • Manual dental scaler, reusable
Molar Band LR 35 w/10
ADITEK DO BRASIL S/A
04.01.4350
In Commercial Distribution

  • 07899439234086 ()


  • Orthodontic metal band
Molar Band LL 35 w/10
ADITEK DO BRASIL S/A
04.01.3350
In Commercial Distribution

  • 07899439233799 ()


  • Orthodontic metal band
Molar Band UL 35 w/10
ADITEK DO BRASIL S/A
04.01.2350
In Commercial Distribution

  • 07899439233508 ()


  • Orthodontic metal band
Molar Band UR 35 w/10
ADITEK DO BRASIL S/A
04.01.1350
In Commercial Distribution

  • 07899439233218 ()


  • Orthodontic metal band
DOMED PATELLA TRIAL 35 X 10MM
Encore Medical, L.P.
802-01-110
In Commercial Distribution

  • 00888912135306 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
DOMED KNEE PATELLA TRIALS, SZ 35
Encore Medical, L.P.
802-01-097
In Commercial Distribution

  • 00888912135207 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
Test Hedstrom Files, #35 - 6 Pack
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-11304
Not in Commercial Distribution

  • H834012113041 ()
  • 10381780510390 ()
  • 00381780510393 ()
012-11304

  • Manual endodontic file/rasp, single-use
Pow-R NiTi. 04 Files #35 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-16046
Not in Commercial Distribution

  • H834012160461 ()
  • 10381780483212 ()
  • 00381780483215 ()
012-16046

  • Manual endodontic file/rasp, single-use
Pow-R NiTi. 04 Files #35 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-16034
Not in Commercial Distribution

  • H834012160341 ()
  • 10381780483168 ()
  • 00381780483161 ()
012-16034

  • Manual endodontic file/rasp, single-use
Onyx-H™ Hedstrom Files #35 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-15104
Not in Commercial Distribution

  • H834012151041 ()
  • 10381780482871 ()
  • 00381780482874 ()
012-15104

  • Manual endodontic file/rasp, single-use
Onyx-H™ Hedstrom Files #35 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-15084
Not in Commercial Distribution

  • H834012150841 ()
  • 10381780482819 ()
  • 00381780482812 ()
012-15084

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #35 31mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12187
Not in Commercial Distribution

  • H834012121871 ()
  • 10381780481911 ()
  • 00381780481914 ()
012-12187

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #35 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12067
Not in Commercial Distribution

  • H834012120671 ()
  • 10381780481775 ()
  • 00381780481778 ()
012-12067

  • Manual endodontic file/rasp, single-use
Union Broach® Reamers #35 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-12008
Not in Commercial Distribution

  • H834012120081 ()
  • 10381780481638 ()
  • 00381780481631 ()
012-12008

  • Manual endodontic file/rasp, single-use
Sharpie® Hedstrom Files #35 31mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-11184
Not in Commercial Distribution

  • H834012111841 ()
  • 10381780481461 ()
  • 00381780481464 ()
012-11184

  • Manual endodontic file/rasp, single-use
Sharpie® Hedstrom Files #35 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-11064
Not in Commercial Distribution

  • H834012110641 ()
  • 10381780481300 ()
  • 00381780481303 ()
012-11064

  • Manual endodontic file/rasp, single-use
Sharpie® Hedstrom Files #35 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-11005
Not in Commercial Distribution

  • H834012110051 ()
  • 10381780481164 ()
  • 00381780481167 ()
012-11005

  • Manual endodontic file/rasp, single-use
Mor-Flex® Files, K-Type #35 31mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-10187
Not in Commercial Distribution

  • H834012101871 ()
  • 10381780480976 ()
  • 00381780480979 ()
012-10187

  • Manual endodontic file/rasp, single-use
Mor-Flex® Files, K-Type #35 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-10067
Not in Commercial Distribution

  • H834012100671 ()
  • 10381780480792 ()
  • 00381780480795 ()
012-10067

  • Manual endodontic file/rasp, single-use
Mor-Flex® Files, K-Type #35 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-10008
Not in Commercial Distribution

  • H834012100081 ()
  • 10381780480648 ()
  • 00381780480641 ()
012-10008

  • Manual endodontic file/rasp, single-use
OSTEOTOME JACK WITH SCREWDRIVER, 35 MM
ARTHREX, INC.
AR-13323-35S
In Commercial Distribution

  • 00888867011328 ()
AR-13323-35S

  • Orthopaedic surgical distractor, internal
EndoMagic!® #35, 25mm K-Files-5/Pk
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
EMF2535
Not in Commercial Distribution

  • 10381780498506 ()
  • 00381780498509 ()
EMF2535

  • Manual endodontic file/rasp, reusable
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