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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LOCATOR Abutment for Duraplant, 3.1mm External Hex, 3.0mm Cuff
Zest Anchors, LLC
08489
In Commercial Distribution

  • 00840481133374 ()

  • Length: 3 Millimeter


  • Dental implant suprastructure, permanent, preformed
LOCATOR Abutment for Duraplant, 3.1mm External Hex, 2.0mm Cuff
Zest Anchors, LLC
08488
In Commercial Distribution

  • 00840481133367 ()

  • Length: 2 Millimeter


  • Dental implant suprastructure, permanent, preformed
LOCATOR Abutment for Duraplant, 3.1mm External Hex, 1.0mm Cuff
Zest Anchors, LLC
08487
In Commercial Distribution

  • 00840481133350 ()

  • Length: 1 Millimeter


  • Dental implant suprastructure, permanent, preformed
MILLABLE POST, REP., EXTERNAL PROF., PRE-KOH TG,MEDIUM PLAT.
SWEDEN & MARTINA SPA
A-TG-MFE-M
In Commercial Distribution

  • D7700875793 ()
A-TG-MFE-M

  • Dental implant suprastructure, permanent, preformed
MILLABLE POST, REP., EXTERNAL PROF., PRE-KOH TG, WIDE PLAT.
SWEDEN & MARTINA SPA
A-TG-MFE-W
In Commercial Distribution

  • D7700875803 ()
A-TG-MFE-W

  • Dental implant suprastructure, permanent, preformed
No Description
BIOMET SPINE LLC
6213
In Commercial Distribution

  • 00888480398615 ()

  • EXTERNAL HEX SET SCREW (TI)
6213

  • Bone-screw internal spinal fixation system, non-sterile
Integra® External Fixation System The provisional midfoot support is used with the external fixation system.
Ascension Orthopedics, Inc.
12225060
In Commercial Distribution

  • M269122250601 ()
  • 10381780248132 ()

  • 5.702 in L
12225060

  • External orthopaedic fixation system, reusable
Integra® External Fixation System The provisional heel support is used with the external fixation system.
Ascension Orthopedics, Inc.
12225050
In Commercial Distribution

  • M269122250501 ()
  • 10381780248125 ()

  • 6.238 in L
12225050

  • External orthopaedic fixation system, reusable
Integra® External Fixation System The provisional calf support is used with the external fixation system.
Ascension Orthopedics, Inc.
12225040
In Commercial Distribution

  • M269122250401 ()
  • 10381780248118 ()

  • 6.883 in L
12225040

  • External orthopaedic fixation system, reusable
ROD D 12 MM L 350 MM
ORTHOFIX SRL
1
In Commercial Distribution

  • 18033509859328 ()

  • Length: 350 Millimeter
  • Outer Diameter: 12 Millimeter
932350

  • External orthopaedic fixation system, single-use
aerFree AMS utilizes patented aer+TM technology to simply and safely support the patency of the upper airway during medical procedures requiring mild to moderate levels of sedation. It is FDA-cleared for airway management in adults undergoing medical procedures of less than 2 hours in duration, where the patient is intended to receive mild to moderate sedation with non-propofol containing medications.
Sommetrics
30-5001
In Commercial Distribution

  • 00851167007001 ()
30-5001

  • External negative-pressure airway patency collar
Integra® Miltex® Collyer Pelvimeter, 11-1/2", Graduated in Centimeters and inches
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
30-2235
In Commercial Distribution

  • H8343022350 ()
  • 10381780495086 ()
30-2235

  • Pelvimeter
Integra® Miltex® Martin Pelvimeter, 13-1/2", Graduated in Centimeters and Inches
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
30-2230
In Commercial Distribution

  • H8343022300 ()
  • 10381780495079 ()
30-2230

  • Pelvimeter
INFINITY EXTERNAL 4.75X15.0MM Ø5.0HD HEX IMPLANT TI CP GRADE 4
ACE SURGICAL SUPPLY CO., INC.
404715
In Commercial Distribution

  • 00614950005543 ()

  • Length: 15 Millimeter
404715

  • Dental implant suprastructure, permanent, preformed
INFINITY EXTERNAL 4.75X13MM Ø5.0HD HEX IMPLANT TI CP GRADE 4
ACE SURGICAL SUPPLY CO., INC.
404713
In Commercial Distribution

  • 00614950005536 ()

  • Length: 13 Millimeter
404713

  • Dental implant suprastructure, permanent, preformed
INFINITY EXTERNAL 4.75X11.5MM Ø5.0HD HEX IMPLANT TI CP GRADE 4
ACE SURGICAL SUPPLY CO., INC.
404711
In Commercial Distribution

  • 00614950005529 ()

  • Length: 11.5 Millimeter
404711

  • Dental implant suprastructure, permanent, preformed
INFINITY EXTERNAL 4.75X10.0MM Ø5.0HD HEX IMPLANT TI CP GRADE 4
ACE SURGICAL SUPPLY CO., INC.
404710
In Commercial Distribution

  • 00614950005512 ()

  • Length: 10 Millimeter
404710

  • Dental implant suprastructure, permanent, preformed
INFINITY EXTERNAL 4.75X8.0MM Ø5.0HD HEX IMPLANT TI CP GRADE 4
ACE SURGICAL SUPPLY CO., INC.
404708
In Commercial Distribution

  • 00614950005505 ()

  • Length: 8 Millimeter
404708

  • Dental implant suprastructure, permanent, preformed
INFINITY EXTERNAL 4.0X15MM Ø4.0HD HEX IMPLANT TI CP GRADE 4
ACE SURGICAL SUPPLY CO., INC.
404015
In Commercial Distribution

  • 00614950005499 ()

  • Length: 15 Millimeter
404015

  • Dental implant suprastructure, permanent, preformed
INFINITY EXTERNAL 4.0X13.0MM Ø4.0HD HEX IMPLANT TI CP GRADE 4
ACE SURGICAL SUPPLY CO., INC.
404013
In Commercial Distribution

  • 00614950005482 ()

  • Length: 13 Millimeter
404013

  • Dental implant suprastructure, permanent, preformed
INFINITY EXTERNAL 4.0X11.5MM Ø4.0HD HEX IMPLANT TI CP GRADE 4
ACE SURGICAL SUPPLY CO., INC.
404011
In Commercial Distribution

  • 00614950005475 ()

  • Length: 11.5 Millimeter
404011

  • Dental implant suprastructure, permanent, preformed
INFINITY EXTERNAL 4.0X10.0MM Ø4.0HD HEX IMPLANT TI CP GRADE 4
ACE SURGICAL SUPPLY CO., INC.
404010
In Commercial Distribution

  • 00614950005468 ()

  • Length: 10 Millimeter
404010

  • Dental implant suprastructure, permanent, preformed
INFINITY EXTERNAL 4.0X8.0MM Ø4.0HD HEX IMPLANT TI CP GRADE 4
ACE SURGICAL SUPPLY CO., INC.
404008
In Commercial Distribution

  • 00614950005451 ()

  • Length: 8 Millimeter
404008

  • Dental implant suprastructure, permanent, preformed
INFINITY EXTERNAL 3.75X15.0MM Ø4.0HD HEX IMPLANT TI CP GRADE 4
ACE SURGICAL SUPPLY CO., INC.
403715
In Commercial Distribution

  • 00614950005444 ()

  • Length: 8 Millimeter
403715

  • Dental implant suprastructure, permanent, preformed
INFINITY EXTERNAL 3.75X13.0MM Ø4.0HD HEX IMPLANT TI CP GRADE 4
ACE SURGICAL SUPPLY CO., INC.
403713
In Commercial Distribution

  • 00614950005437 ()

  • Length: 13 Millimeter
403713

  • Dental implant suprastructure, permanent, preformed
INFINITY EXTERNAL 3.75X11.5MM Ø4.0HD HEX IMPLANT TI CP GRADE 4
ACE SURGICAL SUPPLY CO., INC.
403711
In Commercial Distribution

  • 00614950005420 ()

  • Length: 11.5 Millimeter
403711

  • Dental implant suprastructure, permanent, preformed
INFINITY EXTERNAL 3.75X10.0MM Ø4.0HD HEX IMPLANT TI CP GRADE 4
ACE SURGICAL SUPPLY CO., INC.
403710
In Commercial Distribution

  • 00614950005413 ()

  • Length: 10 Millimeter
403710

  • Dental implant suprastructure, permanent, preformed
INFINITY EXTERNAL 3.75X8.0MM Ø4.0HD HEX IMPLANT TI CP GRADE 4
ACE SURGICAL SUPPLY CO., INC.
403708
In Commercial Distribution

  • 00614950005406 ()

  • Length: 8 Millimeter
403708

  • Dental implant suprastructure, permanent, preformed
INFINITY EXTERNAL 3.3X8.0MM Ø3.5HD HEX IMPLANT TI CP GRADE 4
ACE SURGICAL SUPPLY CO., INC.
403308
In Commercial Distribution

  • 00614950005352 ()

  • Length: 8 Millimeter
403308

  • Dental implant suprastructure, permanent, preformed
Lateral Expandable Cage External, Size 21x25 mm 36-42, 0 Deg.
K2M, INC.
1713-204225EL0
In Commercial Distribution

  • 10888857023963 ()

  • Height: 42 Millimeter
  • Width: 25 Millimeter
  • Length: 21 Millimeter
1713-204225EL0

  • Vertebral body prosthesis
Mayo-Myers External Vein Stripper 15" Straight, Internal Ring Size 10mm
Avalign Technologies, Inc.
1-SU11855037
In Commercial Distribution

  • 00190776393762 ()


  • Vein stripper, reusable
Mayo-Myers External Vein Stripper 15" Straight, Internal Ring Size 7mm
Avalign Technologies, Inc.
1-SU11855028
In Commercial Distribution

  • 00190776393328 ()


  • Vein stripper, reusable
Integra® External Fixation System The AO t-handle is used in conjunction with the external fixation system.
Ascension Orthopedics, Inc.
5010001000
In Commercial Distribution

  • M26950100010001 ()
  • 10381780248026 ()

  • 4.399 in L handle
5010001000

  • Surgical instrument handle, non-torque-limiting
CATHETER,EXTERNAL,MALE,EXO,LTX,SM,25MM
MEDLINE INDUSTRIES, INC.
DYND12303
In Commercial Distribution

  • 40080196030928 ()
  • 10080196030927 ()
DYND12303

  • Cystographic/urethrographic catheter, male
CATHETER,EXTERNAL,MALE,EXO,LTX,MED,30MM
MEDLINE INDUSTRIES, INC.
DYND12302
In Commercial Distribution

  • 40080196030904 ()
  • 10080196030903 ()
DYND12302

  • Cystographic/urethrographic catheter, male
CATHETER,EXTERNAL,MALE,EXO,LTX,LG,35MM
MEDLINE INDUSTRIES, INC.
DYND12301
In Commercial Distribution

  • 40080196030898 ()
  • 10080196030897 ()
DYND12301

  • Cystographic/urethrographic catheter, male
18:1 Contra Angle Drill, External Irrigation
OSTEOMED LLC
450-0222
In Commercial Distribution

  • 00845694012447 ()
450-0222

  • General internal orthopaedic fixation system implantation kit
2462491 Agilent 50 Series TOCO External Cable
Advantage Medical Electronics, LLC
CB-2462491
In Commercial Distribution

  • 00849593010399 ()


  • Electrical-only medical device connection cable, reusable
DRG External Pulse Generator, 2 Port Header
ST. JUDE MEDICAL, INC.
7032
In Commercial Distribution

  • 05415067027863 ()
7032

  • Personal device holder, reusable
Multifunctional Implant mount - External Hex w/ screw
ODONTIT S.A.
IM
In Commercial Distribution

  • D914IM0 ()
IM

  • Screw endosteal dental implant, two-piece
100:1 Contra Angle Drill, External Irrigation
OSTEOMED LLC
450-0232
In Commercial Distribution

  • 00845694089975 ()
450-0232

  • General internal orthopaedic fixation system implantation kit
External 5.0mm Abutment for Screw, 3.5mm Collar
BIOHORIZONS IMPLANT SYSTEMS, INC
AFS503
Not in Commercial Distribution

  • 00847236000257 ()


  • Dental implant suprastructure, permanent, preformed
External 5.0mm Abutment for Screw, 4.5mm Collar
BIOHORIZONS IMPLANT SYSTEMS, INC
AFS504
Not in Commercial Distribution

  • 00847236000240 ()


  • Dental implant suprastructure, permanent, preformed
External 4.0mm Abutment for Screw, 4.5mm Collar
BIOHORIZONS IMPLANT SYSTEMS, INC
AFS404
Not in Commercial Distribution

  • 00847236002718 ()


  • Dental implant suprastructure, permanent, preformed
External 4.0mm Abutment for Screw, 3.5mm Collar
BIOHORIZONS IMPLANT SYSTEMS, INC
AFS403
Not in Commercial Distribution

  • 00847236002701 ()


  • Dental implant suprastructure, permanent, preformed
External 3.5mm Abutment for Screw, 4.5mm Collar
BIOHORIZONS IMPLANT SYSTEMS, INC
AFS354
Not in Commercial Distribution

  • 00847236002688 ()


  • Dental implant suprastructure, permanent, preformed
External 3.5mm Abutment for Screw, 3.5mm Collar
BIOHORIZONS IMPLANT SYSTEMS, INC
AFS353
Not in Commercial Distribution

  • 00847236002671 ()


  • Dental implant suprastructure, permanent, preformed
External 4/5/6.0mm Direct Pick-up Screw
BIOHORIZONS IMPLANT SYSTEMS, INC
244-320
In Commercial Distribution

  • 00847236002442 ()


  • Dental implant suprastructure, temporary, preformed, single-use
External 6.0mm x 6mm Flared Healing Abutment
BIOHORIZONS IMPLANT SYSTEMS, INC
212-606
Not in Commercial Distribution

  • 00847236002145 ()


  • Dental implant suprastructure, temporary, preformed, single-use
External 6.0mm x 4.5mm Flared Healing Abutment
BIOHORIZONS IMPLANT SYSTEMS, INC
212-604
In Commercial Distribution

  • 00847236002138 ()


  • Dental implant suprastructure, temporary, preformed, single-use
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