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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Hyflex NT 06/35 x 25mm File
COLTENE/WHALEDENT INC
HNT8250635
In Commercial Distribution

  • D661HNT82506351 ()
  • D661HNT82506350 ()


  • Rotary/reciprocating endodontic file/rasp, reusable
Hyflex NT 04/35 x 25mm File
COLTENE/WHALEDENT INC
HNT8250435
In Commercial Distribution

  • D661HNT82504351 ()
  • D661HNT82504350 ()


  • Rotary/reciprocating endodontic file/rasp, reusable
Hyflex NT 06/35 x 21mm File
COLTENE/WHALEDENT INC
HNT8210635
In Commercial Distribution

  • D661HNT82106351 ()
  • D661HNT82106350 ()


  • Rotary/reciprocating endodontic file/rasp, reusable
Hyflex NT 04/35 x 21mm File
COLTENE/WHALEDENT INC
HNT8210435
In Commercial Distribution

  • D661HNT82104351 ()
  • D661HNT82104350 ()


  • Rotary/reciprocating endodontic file/rasp, reusable
Hyflex CM 06/35 x 31mm File
COLTENE/WHALEDENT INC
H8310635
In Commercial Distribution

  • D661H83106351 ()
  • D661H83106350 ()


  • Rotary/reciprocating endodontic file/rasp, reusable
Hyflex CM 04/35 x 31mm File
COLTENE/WHALEDENT INC
H8310435
In Commercial Distribution

  • D661H83104351 ()
  • D661H83104350 ()


  • Rotary/reciprocating endodontic file/rasp, reusable
Hyflex CM 06/35 x 25mm File
COLTENE/WHALEDENT INC
H8250635
In Commercial Distribution

  • D661H82506351 ()
  • D661H82506350 ()


  • Rotary/reciprocating endodontic file/rasp, reusable
Hyflex CM 04/35 x 25mm File
COLTENE/WHALEDENT INC
H8250435
In Commercial Distribution

  • D661H82504351 ()
  • D661H82504350 ()


  • Rotary/reciprocating endodontic file/rasp, reusable
Hyflex CM 06/35 x 21mm File
COLTENE/WHALEDENT INC
H8210635
In Commercial Distribution

  • D661H82106351 ()
  • D661H82106350 ()


  • Rotary/reciprocating endodontic file/rasp, reusable
Hyflex CM 04/35 x 21mm File
COLTENE/WHALEDENT INC
H8210435
In Commercial Distribution

  • D661H82104351 ()
  • D661H82104350 ()


  • Rotary/reciprocating endodontic file/rasp, reusable
Hyflex X-File NT #35 x 25mm File
COLTENE/WHALEDENT INC
H08404
Not in Commercial Distribution

  • D661H084041 ()
  • D661H084040 ()


  • Rotary/reciprocating endodontic file/rasp, reusable
Hyflex X-File NT #35 x 21mm File
COLTENE/WHALEDENT INC
H08382
Not in Commercial Distribution

  • D661H083821 ()
  • D661H083820 ()


  • Rotary/reciprocating endodontic file/rasp, reusable
SHORT TOOTH COUNTER BLADE, 35 MM, TITANIUM
TEDAN SURGICAL INNOVATIONS, L.L.C.
ML-0246
In Commercial Distribution

  • 00843059112801 ()


  • Surgical retractor/retraction system blade, reusable
BLUNT BLADE, 23 X 35 MM, TITANIUM
TEDAN SURGICAL INNOVATIONS, L.L.C.
CS-1031
In Commercial Distribution

  • 00843059107562 ()


  • Surgical retractor/retraction system blade, reusable
BLUNT BLADE, 20 X 35 MM, BLUE
TEDAN SURGICAL INNOVATIONS, L.L.C.
CS-0031
In Commercial Distribution

  • 00843059105162 ()


  • Surgical retractor/retraction system blade, reusable
BLUNT BLADE, 23 X 35 MM, BLUE
TEDAN SURGICAL INNOVATIONS, L.L.C.
CS-0021
In Commercial Distribution

  • 00843059105063 ()


  • Surgical retractor/retraction system blade, reusable
CONICAL DELTA STYLE BLADE, 35 MM, TITANIUM
TEDAN SURGICAL INNOVATIONS, L.L.C.
CS-1731C
In Commercial Distribution

  • 00843059108668 ()


  • Surgical retractor/retraction system blade, reusable
DISCECTOMY BLADE, 23 X 35 MM, TITANIUM
TEDAN SURGICAL INNOVATIONS, L.L.C.
CS-0341
In Commercial Distribution

  • 00843059107203 ()


  • Surgical retractor/retraction system blade, reusable
Nasal Speculum KILLIAN Fig. 1 35 mm
Kohler Medizintechnik GmbH
5739
In Commercial Distribution

  • 04251436915819 ()
5739

  • Hand-held dental retractor
Symmetric Patella Trial, Size 35, 9mm thickness
B-ONE ORTHO, CORP.
8829407359
In Commercial Distribution

  • 00843575100566 ()
8829407359

  • Patella prosthesis trial
Golden K File SS-Size #35 25mm Length
GoldenDent
GK35
In Commercial Distribution

  • 00850028211571 ()
  • 00850011211472 ()
GK35

  • Manual endodontic file/rasp, reusable
Band Bag Nose Shape 89x120cm - 35"x47"
EXACT MEDICAL MANUFACTURING, INC.
E5476N
Not in Commercial Distribution

  • 00850024023727 ()
  • 00850024023710 ()
E5476N

  • Medical equipment/instrument drape, single-use
dentaform® Band, Tooth 16, Size 35
DENTAURUM GmbH & Co.KG
882-035-00
In Commercial Distribution

  • J011882035000 ()
  • J011882035001 ()


  • Orthodontic metal band
CONNECTOR 5763235 6.35-6.0 SIDE LAT 35 S
MEDTRONIC SOFAMOR DANEK, INC.
5763235
In Commercial Distribution

  • 00643169227712 ()

  • Width: 5.5 Millimeter
  • Length: 35.0 Millimeter
  • Height: 4.75 Millimeter


  • Bone-screw internal spinal fixation system connector
CONNECTOR 5463235 4.75-6.0 SIDE LAT 35 S
MEDTRONIC SOFAMOR DANEK, INC.
5463235
Not in Commercial Distribution

  • 00643169227538 ()

  • 4.75mm x 6.0mm x 35mm


  • Bone-screw internal spinal fixation system, sterile
CONNECTOR 5453235 4.75-5.5 SIDE LAT 35 S
MEDTRONIC SOFAMOR DANEK, INC.
5453235
Not in Commercial Distribution

  • 00643169227309 ()

  • Height: 4.75 Millimeter
  • Width: 5.5 Millimeter
  • Length: 35.0 Millimeter


  • Bone-screw internal spinal fixation system, sterile
CONNECTOR 5443235 4.75-4.75 SID LAT 35 S
MEDTRONIC SOFAMOR DANEK, INC.
5443235
Not in Commercial Distribution

  • 00643169227200 ()

  • Length: 35.0 Millimeter


  • Bone-screw internal spinal fixation system, sterile
dentaform® Band, Tooth 36, Size 35
DENTAURUM GmbH & Co.KG
885-035-00
In Commercial Distribution

  • J011885035000 ()
  • J011885035001 ()


  • Orthodontic metal band
dentaform® Band, Tooth 46, Size 35
DENTAURUM GmbH & Co.KG
884-035-00
In Commercial Distribution

  • J011884035000 ()
  • J011884035001 ()


  • Orthodontic metal band
SCREW 55811016035 CNSAS 6.0 X 35 CC
MEDTRONIC SOFAMOR DANEK, INC.
55811016035
In Commercial Distribution

  • 00643169065901 ()

  • Length: 35.0 Millimeter
  • Outer Diameter: 6.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
SCREW 55811017035 CNSAS 7.0 X 35 CC
MEDTRONIC SOFAMOR DANEK, INC.
55811017035
In Commercial Distribution

  • 00643169065789 ()

  • Length: 35.0 Millimeter
  • Outer Diameter: 7.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
SCREW 55811016535 CNSAS 6.5 X 35 CC
MEDTRONIC SOFAMOR DANEK, INC.
55811016535
In Commercial Distribution

  • 00643169065628 ()

  • Length: 35.0 Millimeter
  • Outer Diameter: 6.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
SCREW 55811015035 CNSAS 5.0 X 35 CC
MEDTRONIC SOFAMOR DANEK, INC.
55811015035
In Commercial Distribution

  • 00643169065581 ()

  • Outer Diameter: 5.0 Millimeter
  • Length: 35.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
SCREW 55811014535 CNSAS 4.5 X 35 CC
MEDTRONIC SOFAMOR DANEK, INC.
55811014535
In Commercial Distribution

  • 00643169065444 ()

  • Length: 35.0 Millimeter
  • Outer Diameter: 4.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
SCREW 55811015535 CNSAS 5.5 X 35 CC
MEDTRONIC SOFAMOR DANEK, INC.
55811015535
In Commercial Distribution

  • 00643169065307 ()

  • Length: 35.0 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
SCREW 55811019035 CNSAS 9.0 X 35 CC
MEDTRONIC SOFAMOR DANEK, INC.
55811019035
In Commercial Distribution

  • 00643169065123 ()

  • Length: 35.0 Millimeter
  • Outer Diameter: 9.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
SCREW 55811019535 CNSAS 9.5 X 35 CC
MEDTRONIC SOFAMOR DANEK, INC.
55811019535
In Commercial Distribution

  • 00643169064843 ()

  • Outer Diameter: 9.5 Millimeter
  • Length: 35.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
SCREW 55811018535 CNSAS 8.5 X 35 CC
MEDTRONIC SOFAMOR DANEK, INC.
55811018535
In Commercial Distribution

  • 00643169064744 ()

  • Length: 35.0 Millimeter
  • Outer Diameter: 8.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
SCREW 55811017535 CNSAS 7.5 X 35 CC
MEDTRONIC SOFAMOR DANEK, INC.
55811017535
In Commercial Distribution

  • 00643169064645 ()

  • Length: 35.0 Millimeter
  • Outer Diameter: 7.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
SCREW 55811018035 CNSAS 8.0 X 35 CC
MEDTRONIC SOFAMOR DANEK, INC.
55811018035
In Commercial Distribution

  • 00643169064362 ()

  • Outer Diameter: 8.0 Millimeter
  • Length: 35.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
ROD 7753835 PRE-CUT 3.5MM X 35 CCM+
MEDTRONIC SOFAMOR DANEK, INC.
7753835
In Commercial Distribution

  • 00643169056244 ()

  • Length: 35.0 Millimeter
  • Outer Diameter: 3.5 Millimeter


  • Bone-screw internal spinal fixation system rod
EXACTGUIDE PAPER POINTS 35/.06 - 100 PACK
Ss White Burs, Inc.
UPPTG3506
In Commercial Distribution

  • D690PPTG35062 ()
PPTG3506

  • Endodontic paper point
EXACTGUIDE PAPER POINTS 35/.04 - 100 PACK
Ss White Burs, Inc.
UPPTG3504
In Commercial Distribution

  • D690PPTG35042 ()
PPTG3504

  • Endodontic paper point
EXACTGUIDE GUTTA PERCHA 35/.06 - 60 PACK
Ss White Burs, Inc.
UGPTG3506
In Commercial Distribution

  • D690GPTG35062 ()
GPTG3506

  • Natural gutta-percha
EXACTGUIDE GUTTA PERCHA 35/.04 - 60 PACK
Ss White Burs, Inc.
UGPTG3504
In Commercial Distribution

  • D690GPTG35042 ()
GPTG3504

  • Natural gutta-percha
FG CARBIDE 35 SHORT SHANK - 10 PACK
Ss White Burs, Inc.
FG-PBUR-35S
In Commercial Distribution

  • D690150420 ()
  • D690150422 ()
15042

  • Carbide dental bur, single-use
FG CARBIDE 35 SHORT SHANK - BULK 100
Ss White Burs, Inc.
FG-PBUR-35S
In Commercial Distribution

  • D690130530 ()
  • D690130532 ()
13053

  • Carbide dental bur, reusable
SEMI-GEL, 35% PHOSPHORIC ACID 18 gm bottle
PULPDENT CORPORATION
ET18
In Commercial Distribution

  • D701ET182 ()


  • Dental etching solution
HYFLEX NT FILE 21MM 06/35 6PK
COLTENE/WHALEDENT INC
SBHNT8210635
In Commercial Distribution

  • D661SBHNT82106350 ()
  • D661SBHNT82106351 ()


  • Rotary/reciprocating endodontic file/rasp, reusable
HYFLEX NT FILE 21MM 04/35 6PK
COLTENE/WHALEDENT INC
SBHNT8210435
In Commercial Distribution

  • D661SBHNT82104350 ()
  • D661SBHNT82104351 ()


  • Rotary/reciprocating endodontic file/rasp, reusable
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