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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OBTURATOR - VUL20 - SIZE 35 VC Obt 20pk
HENRY SCHEIN, INC.
2020332
In Commercial Distribution

  • 10304040115173 ()
  • 00304040115176 ()
2020332

  • Warm-bonded endodontic obturation system obturator
OBTURATOR - OBT6 - SIZE 35 Obt 6pk- CHC3.5
HENRY SCHEIN, INC.
2020310
In Commercial Distribution

  • 10304040109851 ()
  • 00304040109854 ()
2020310

  • Warm-bonded endodontic obturation system obturator
Journey II Interchangeable Drill Plate - Sizes 3-5
Orthalign, Inc.
402146
In Commercial Distribution

  • 00810832031024 ()
402146

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Vital™ MIS P.A.T. 35 mm Stylus
ZIMMER BIOMET INC
850M3035
In Commercial Distribution

  • 00887868309830 ()


  • Bone awl, reusable
Transverse Connector - 4 mm Rod - 35 mm
ZIMMER BIOMET INC
721-4035
In Commercial Distribution

  • 00887868284694 ()


  • Bone-screw internal spinal fixation system, non-sterile
HYGENIC® Absorbent Paper Points ISO 35
Coltène/Whaledent GmbH + Co. KG
H02117
In Commercial Distribution

  • E165H021170 ()
  • E165H021171 ()
H02117

  • Endodontic paper point
MicroMega One RECI Paper Points 0.04 # 35
Coltène/Whaledent GmbH + Co. KG
60031748
In Commercial Distribution

  • E165600317480 ()
  • E165600317482 ()
60031748

  • Endodontic paper point
MicroMega One RECI Guttapercha Points 0.04 #35
Coltène/Whaledent GmbH + Co. KG
60031553
In Commercial Distribution

  • E165600315530 ()
  • E165600315531 ()
60031553

  • Root canal obturating point
HyFlex™ CM Guttapercha Points 0.06 # 35
Coltène/Whaledent GmbH + Co. KG
60022700
In Commercial Distribution

  • E165600227000 ()
  • E165600227001 ()
60022700

  • Root canal obturating point
HyFlex™ CM Guttapercha Points 0.04 # 35
Coltène/Whaledent GmbH + Co. KG
60022692
In Commercial Distribution

  • E165600226920 ()
  • E165600226921 ()
60022692

  • Root canal obturating point
HyFlex™ CM Paper Points 0.06 # 35
Coltène/Whaledent GmbH + Co. KG
60022685
In Commercial Distribution

  • E165600226850 ()
  • E165600226851 ()
60022685

  • Endodontic paper point
HyFlex™ CM Paper Points 0.04 # 35
Coltène/Whaledent GmbH + Co. KG
60022675
In Commercial Distribution

  • E165600226750 ()
  • E165600226751 ()
60022675

  • Endodontic paper point
ROEKO Guttapercha Points Top color ISO 35
Coltène/Whaledent GmbH + Co. KG
365135
In Commercial Distribution

  • E1653651350 ()
  • E1653651351 ()
365135

  • Root canal obturating point
ROEKO Paper Points Top color ISO 35
Coltène/Whaledent GmbH + Co. KG
344535
In Commercial Distribution

  • E1653445350 ()
  • E1653445351 ()
344535

  • Endodontic paper point
35 FGSS Clinic Pack Carbide Burs (100)
Hager & Meisinger Gesellschaft mit beschränkter Haftung
C0035SS
In Commercial Distribution

  • E0HM72C0035SS1 ()
C0035SS

  • Carbide dental bur, reusable
5.0 mm Locking Screw 35 mm Length
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
LSC5-035
In Commercial Distribution

  • 00812258021542 ()

  • Outer Diameter: 5.0 Millimeter
LSC5-035

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
4.0 mm Locking Screw 35 mm Length
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
LSC4-035
In Commercial Distribution

  • 00812258021450 ()

  • Outer Diameter: 4.0 Millimeter
LSC4-035

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
3.5 mm Locking Screw 35 mm Length
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
LSB3-035
In Commercial Distribution

  • 00812258021368 ()

  • Outer Diameter: 3.5 Millimeter
LSB3-035

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Simmetry Implant 12.5 mm x 35 mm
Sivantage, Inc.
B
In Commercial Distribution

  • 00810142530668 ()

  • 12.5 mm x 35 mm
10-P12535-01

  • Sacroiliac joint intra-articular arthrodesis implant
Paste Fillers SS 21mm #35 4/Pk
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
PF2135
In Commercial Distribution

  • 00810126502575 ()
PF2135

  • Manual endodontic file/rasp, single-use
K-FILE Flex Type 21mm #35 6/Pk
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
KF2135
Not in Commercial Distribution

  • 00810126501363 ()
KF2135

  • Manual endodontic file/rasp, single-use
Hedstrom Files SS 31mm #35 6/Pk
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
HS3135
In Commercial Distribution

  • 00810126501202 ()
HS3135

  • Manual endodontic file/rasp, single-use
Hedstrom Files NiTi 31mm #35 6/Pk
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
HN3135
In Commercial Distribution

  • 00810126500694 ()
HN3135

  • Manual endodontic file/rasp, single-use
Hedstrom Files NiTi 25mm #35 6/Pk
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
HN2535
In Commercial Distribution

  • 00810126500533 ()
HN2535

  • Manual endodontic file/rasp, single-use
Hedstrom Files NiTi 21mm #35 6/Pk
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
HN2135
In Commercial Distribution

  • 00810126500373 ()
HN2135

  • Manual endodontic file/rasp, single-use
Finger Spreaders SS 21mm #35 6/Pk
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
FS2135
In Commercial Distribution

  • 00810126500199 ()
FS2135

  • Endodontic obturation material distribution endpiece, single-use
Finger Pluggers SS 25mm #35 6/Pk
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
FP2535
In Commercial Distribution

  • 00810126500113 ()
FP2535

  • Endodontic obturation material distribution endpiece, single-use
Finger Pluggers SS 21mm #35 6/Pk
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
FP2135
In Commercial Distribution

  • 00810126500021 ()
FP2135

  • Endodontic obturation material distribution endpiece, single-use
Sabur Carbide Burs FG #35 100/Pk
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
SB-FG35-100
In Commercial Distribution

  • 00810126505835 ()
SB-FG35-100

  • Carbide dental bur, reusable
Sabur Carbide Burs FG #35 10/Pk
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
SB-FG35-10
In Commercial Distribution

  • 00810126505279 ()
SB-FG35-10

  • Carbide dental bur, reusable
K-File Flex Type 25mm #35 6/Bx
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
KF2535
Not in Commercial Distribution

  • 00810126501493 ()
KF2535

  • Manual endodontic file/rasp, single-use
Hedstrom Files SS 25mm #35 6/Pk
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
HS2535
In Commercial Distribution

  • 00810126501042 ()
HS2535

  • Manual endodontic file/rasp, single-use
Hedstrom Files SS 21mm #35 6/Pk
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
HS2135
In Commercial Distribution

  • 00810126500861 ()
HS2135

  • Manual endodontic file/rasp, single-use
Finger Spreaders SS 25mm #35 6/Pk
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
FS2535
In Commercial Distribution

  • 00810126500274 ()
FS2535

  • Endodontic obturation material distribution endpiece, single-use
SPECIALTY SCORPIO CROSSOVER DRILL GUIDE SIZE 3-5
Howmedica Osteonics Corp.
I-K0820RG35
In Commercial Distribution

  • 07613327326086 ()

  • Lumen/Inner Diameter: 0.625 Inch
I-K0820RG35

  • Surgical drill guide, reusable
HSB - Carbide Burs RA - #35 - 100/Pk
Frontier Dental Supply Inc
HSB-401156
In Commercial Distribution

  • 10810132801423 ()
  • 00810132801426 ()


  • Diamond dental bur, reusable
HSB - Carbide Burs FG - #35 - 100/Pk
Frontier Dental Supply Inc
HSB-401024
In Commercial Distribution

  • 10810132801065 ()
  • 00810132801068 ()


  • Diamond dental bur, reusable
KNIFE HDL NO 3KS RND 3-5/8
Adler, Inc.
21-0190
In Commercial Distribution

  • 00810123204021 ()


  • Scalpel handle, reusable
Ø5.5mm Anti-Rotation Curved Rod , 35 mm Lg.
CAMBER SPINE TECHNOLOGIES, LLC
CP-009-50
In Commercial Distribution

  • B030CP009500 ()

  • Length: 35 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Polymeric spinal interbody fusion cage
Ø5.5mm Anti-Rotation Straight Rod , 35 mm Lg.
CAMBER SPINE TECHNOLOGIES, LLC
CP-008-41
In Commercial Distribution

  • B030CP008410 ()

  • Length: 35 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Polymeric spinal interbody fusion cage
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