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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H-Files 153, 21 mm, # 35, handle SMG
FKG Dentaire Sàrl
01.153.21.035.CG
In Commercial Distribution

  • 07640142414902 ()
01.153.21.035.CG

  • Manual endodontic file/rasp, reusable
INSERTER, PATELLA SIZE32, 35, 38MM TYPE II
DJO, LLC
802-01-091
In Commercial Distribution

  • 00888912135146 ()


  • Patella prosthesis trial
Edge X7 Utopia no 35, 06, 21mm
FKG Dentaire Sàrl
X7U350621SE
In Commercial Distribution

  • 07640142444305 ()
  • 07640142445128 ()
X7U350621SE

  • Rotary/reciprocating endodontic file/rasp, single-use
Edge X7 Utopia no 35, 04, 29mm
FKG Dentaire Sàrl
X7U350429SE
In Commercial Distribution

  • 07640142444237 ()
  • 07640142445050 ()
X7U350429SE

  • Rotary/reciprocating endodontic file/rasp, single-use
Edge X7 Utopia no 35, 04, 21mm
FKG Dentaire Sàrl
X7U350421SE
In Commercial Distribution

  • 07640142444091 ()
  • 07640142444916 ()
X7U350421SE

  • Rotary/reciprocating endodontic file/rasp, single-use
Edge X7 Ultra no 35, 06, 29mm
FKG Dentaire Sàrl
X7U350629S
Not in Commercial Distribution

  • 07640142444442 ()
  • 07640142444022 ()
X7U350629S

  • Rotary/reciprocating endodontic file/rasp, single-use
Edge X7 Ultra no 35, 06, 25mm
FKG Dentaire Sàrl
X7U350625S
Not in Commercial Distribution

  • 07640142444374 ()
  • 07640142443940 ()
X7U350625S

  • Rotary/reciprocating endodontic file/rasp, single-use
Spreaders 111, 25 mm, # 35, handle SMG
FKG Dentaire Sàrl
02.111.25.035.CG
In Commercial Distribution

  • 07640142420316 ()
02.111.25.035.CG

  • Manual endodontic filling material spreader
Pluggers 110, 25 mm, # 35, handle SMG
FKG Dentaire Sàrl
02.110.25.035.CG
In Commercial Distribution

  • 07640142420200 ()
02.110.25.035.CG

  • Endodontic plugger
H-Files 153, 25 mm, # 35, handle SMG
FKG Dentaire Sàrl
01.153.25.035.CG
In Commercial Distribution

  • 07640142415176 ()
01.153.25.035.CG

  • Manual endodontic file/rasp, reusable
SZR/TAMP,TROCHLEAR GROOVE ALOGFT,35 MM
ARTHREX, INC.
AR-4083-35
In Commercial Distribution

  • 00888867032477 ()
AR-4083-35

  • Orthopaedic implant impactor, reusable
LG µPipets®: Holding 35° - PINK (1pc)
LIFEGLOBAL GROUP, LLC
MPHL-35*01*
Not in Commercial Distribution

  • 00815965022093 ()
  • 00815965021904 ()

  • Outer Diameter: 100 Micrometer
  • angle of tip
  • Angle: 35 degree
  • Outer Diameter 100µm
  • Inner Diameter 20µm
  • Lumen/Inner Diameter: 20 Micrometer
MPHL-35*01*

  • Assisted reproduction microtool
Sims Vaginal Specula, 80 x 35/40
Surgical Direct, Inc.
SD91505003
In Commercial Distribution

  • B382SD915050030 ()
SD91505003

  • Vaginal speculum, reusable
Sims Vaginal Specula, 70 x 30/35
Surgical Direct, Inc.
SD91505002
In Commercial Distribution

  • B382SD915050020 ()
SD91505002

  • Vaginal speculum, reusable
ALIF Awl Fixed Angle 35° Short LAG
Medacta International SA
03.30.10.2310
In Commercial Distribution

  • 07630345752970 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
35 Knotless Push-In Suture Anchor with Driver
PARCUS MEDICAL LLC
10994
In Commercial Distribution

  • 00816342023795 ()


  • Tendon/ligament bone anchor, non-bioabsorbable
4.5 X 35 MM BONE SCREW, TWO-LEVEL
INTELLIGENT IMPLANT SYSTEMS, LLC
1164535TL
In Commercial Distribution

  • 00814033020351 ()
1164535TL

  • Bone-screw internal spinal fixation system, sterile
SOMBRERO TRI-PEG PATELLA, 35 X 10mm, e-plus
Encore Medical, L.P.
150-01-735
In Commercial Distribution

  • 00888912108874 ()


  • Cruciate-retaining total knee prosthesis
  • Polyethylene patella prosthesis
Cancellous bone screw Ø 6.5 L 35
Medacta International SA
01.43.0035
In Commercial Distribution

  • 07630971257498 ()


  • Orthopaedic bone screw, non-bioabsorbable, sterile
2110 3W STPCK 22/15 35 & 2OD"
HANS RUDOLPH, INC.
2110
Not in Commercial Distribution

  • 00817136023502 ()
CR1850

  • Pulmonary function valve
AtriClip® Gilinov-Cosgrove LAA Exclusion System 35
ATRICURE, INC.
ACH135
In Commercial Distribution

  • 00818354011357 ()

  • Length: 35 Millimeter
A000688

  • Ligation clip, metallic
Cannulated Polyaxial Pedicle Screw, 7.75 x 35
SPINECRAFT, LLC
SC-P6-7735C
Not in Commercial Distribution

  • M824SCP67735C1 ()


  • Spinal bone screw, non-bioabsorbable
EdgeSequel™ .06 Paper Points™ 35
US ENDODONTICS, LLC
ESS3506PP
In Commercial Distribution

  • 10818365027580 ()
  • 00818365027583 ()
ESS3506PP

  • Endodontic paper point
TQMPL Smart-Blue Gutta Percha Points - 35/.06
TOP QUALITY MANUFACTURING, INC.
12609290
In Commercial Distribution

  • TQ26126092900 ()
  • TQ26126092901 ()


  • Natural gutta-percha
TQMPL Smart-Blue Gutta Percha Points - 35/.04
TOP QUALITY MANUFACTURING, INC.
12609289
In Commercial Distribution

  • TQ26126092890 ()
  • TQ26126092891 ()


  • Natural gutta-percha
TQMPL Smart-Blue Absorbent Paper Points - 35/.06
TOP QUALITY MANUFACTURING, INC.
12609261
In Commercial Distribution

  • TQ26126092610 ()
  • TQ26126092611 ()


  • Endodontic paper point
TQMPL Smart-Blue Absorbent Paper Points - 35/.04
TOP QUALITY MANUFACTURING, INC.
12609260
In Commercial Distribution

  • TQ26126092600 ()
  • TQ26126092601 ()


  • Endodontic paper point
Standard Carbide Bur - Inverted Cone - 35 - FG
TOP QUALITY MANUFACTURING, INC.
12603114
In Commercial Distribution

  • TQ26126031140 ()
  • TQ26126031141 ()


  • Carbide dental bur, reusable
TIBIAL PREP AND IMPACTION PACK SIZE 3-5
DEPUY (IRELAND)
2544-00-101
In Commercial Distribution

  • 10603295129851 ()
254400101

  • Joint prosthesis implantation kit, single-use
Bracket Prescription Roth - Max .022" - 35 - Hook
Dental Morelli Ltda
10.15.428
In Commercial Distribution

  • 07895742108519 ()
10.15.428

  • Orthodontic bracket, metal
Bracket Prescription Roth - Max .018" - 35 - Hook
Dental Morelli Ltda
10.15.328
In Commercial Distribution

  • 07895742108229 ()
10.15.328

  • Orthodontic bracket, metal
Bracket Prescription Roth - Monobloc .022" - 35 - Hook
Dental Morelli Ltda
10.15.215
In Commercial Distribution

  • 07895742061661 ()
10.15.215

  • Orthodontic bracket, metal
Bracket Prescription Roth - Light .018" - 35 - Hook
Dental Morelli Ltda
10.10.331
In Commercial Distribution

  • 07895742049355 ()
10.10.331

  • Orthodontic bracket, metal
Bracket Prescription Roth - Light .022" - 35 - Hook
Dental Morelli Ltda
10.10.431
In Commercial Distribution

  • 07895742049348 ()
10.10.431

  • Orthodontic bracket, metal
Bracket Prescription Roth - Standard .022" - 35 - Hook
Dental Morelli Ltda
10.10.231
In Commercial Distribution

  • 07895742049171 ()
10.10.231

  • Orthodontic bracket, metal
Bracket Prescription Roth - Nano .022" - 35 - Hook
Dental Morelli Ltda
10.15.517
In Commercial Distribution

  • 07895742207960 ()
10.15.517

  • Orthodontic bracket, metal
Bracket Prescription Roth - SLI .022" - 35 - Hook
Dental Morelli Ltda
10.14.015
In Commercial Distribution

  • 07895742202118 ()
10.14.015

  • Self-ligating orthodontic bracket
  • Orthodontic bracket, ceramic
Bracket Prescription M.B.T. - Max .022" - 35 - Hook
Dental Morelli Ltda
10.35.119
In Commercial Distribution

  • 07895742187668 ()
10.35.119

  • Orthodontic bracket, metal
Bracket Prescription M.B.T. - Light .022" - 35 - Hook
Dental Morelli Ltda
10.35.039
In Commercial Distribution

  • 07895742162573 ()
10.35.039

  • Orthodontic bracket, metal
Bracket Prescription M.B.T. - SLI .022" - 35 - Hook
Dental Morelli Ltda
10.27.015
In Commercial Distribution

  • 07895742260507 ()
10.27.015

  • Orthodontic bracket, metal
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