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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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Monkey Rings™ External Fixation System - 00889795114181

Wire Tensioner, Nose, Long
Paragon 28, Inc.
P45-540-0002
In Commercial Distribution

  • 00889795114181 ()
P45-540-0002

  • Orthopaedic inorganic implant inserter/extractor, reusable

Monkey Rings™ External Fixation System - 00889795114174

Wire Tensioner, Nose, Short
Paragon 28, Inc.
P45-540-0001
In Commercial Distribution

  • 00889795114174 ()
P45-540-0001

  • Orthopaedic inorganic implant inserter/extractor, reusable

Monkey Rings™ External Fixation System - 00889795114167

Wire Tensioner, Body
Paragon 28, Inc.
P45-540-0000
In Commercial Distribution

  • 00889795114167 ()
P45-540-0000

  • Orthopaedic inorganic implant inserter/extractor, reusable

JAWS Staple System - 00889795114143

JAW STAPLE SYS, SMOOTH LOC PIN
Paragon 28, Inc.
P70-294-2006
In Commercial Distribution

  • 00889795114143 ()
P70-294-2006

  • Cannulated surgical drill guiding pin

Bun-Yo-Matic™ Lapidus Clamp System - 00889795114129

K-wire Tube, 150mm MAX
Paragon 28, Inc.
P31-941-0150
In Commercial Distribution

  • 00889795114129 ()
P31-941-0150

  • Device sterilization/disinfection container, reusable

APEX 3D Total Ankle Replacement System - 00889795114105

TOTAL ANKLE, INSTRUMENT, TIBIA PILOT PUNCH, RIGHT
Paragon 28, Inc.
P10-951-PPR1
In Commercial Distribution

  • 00889795114105 ()
P10-951-PPR1

  • Bone-coring punch, reusable

APEX 3D Total Ankle Replacement System - 00889795114099

TOTAL ANKLE, INSTRUMENT, TIBIA PILOT PUNCH, LEFT
Paragon 28, Inc.
P10-951-PPL1
In Commercial Distribution

  • 00889795114099 ()
P10-951-PPL1

  • Bone-coring punch, reusable

JAWS Staple System - 00889795114082

JAWS Staple, 12mm, 12 x 12 Straight
Paragon 28, Inc.
P71-012-1212-S
In Commercial Distribution

  • 00889795114082 ()
P71-012-1212-S

  • Orthopaedic bone staple, non-adjustable

Baby Gorilla®/Gorilla® Plating System - 00889795114075

1.60mm x 11cm OLIVE WIRE, Threaded, 316 LVM
Paragon 28, Inc.
P99-251-1611
In Commercial Distribution

  • 00889795114075 ()
P99-251-1611

  • Orthopaedic bone wire

Baby Gorilla®/Gorilla® Plating System - 00889795114068

1.60mm x 11cm OLIVE WIRE, Smooth, 316 LVM
Paragon 28, Inc.
P99-250-1611
In Commercial Distribution

  • 00889795114068 ()
P99-250-1611

  • Orthopaedic bone wire

APEX 3D Total Ankle Replacement System - 00889795114051

Total Ankle, Instrument, Tibia Peg Punch, Right, GEN II, Size 6
Paragon 28, Inc.
P10-851-TPR6
In Commercial Distribution

  • 00889795114051 ()
P10-851-TPR6

  • Bone-coring punch, reusable

APEX 3D Total Ankle Replacement System - 00889795114044

Total Ankle, Instrument, Tibia Peg Punch, Right, GEN II, Size 5
Paragon 28, Inc.
P10-851-TPR5
In Commercial Distribution

  • 00889795114044 ()
P10-851-TPR5

  • Bone-coring punch, reusable

APEX 3D Total Ankle Replacement System - 00889795114037

Total Ankle, Instrument, Tibia Peg Punch, Right, GEN II, Size 4
Paragon 28, Inc.
P10-851-TPR4
In Commercial Distribution

  • 00889795114037 ()
P10-851-TPR4

  • Bone-coring punch, reusable

APEX 3D Total Ankle Replacement System - 00889795114020

Total Ankle, Instrument, Tibia Peg Punch, Right, GEN II, Size 3
Paragon 28, Inc.
P10-851-TPR3
In Commercial Distribution

  • 00889795114020 ()
P10-851-TPR3

  • Bone-coring punch, reusable

APEX 3D Total Ankle Replacement System - 00889795114013

Total Ankle, Instrument, Tibia Peg Punch, Right, GEN II, Size 2
Paragon 28, Inc.
P10-851-TPR2
In Commercial Distribution

  • 00889795114013 ()
P10-851-TPR2

  • Bone-coring punch, reusable

APEX 3D Total Ankle Replacement System - 00889795114006

Total Ankle, Instrument, Tibia Peg Punch, Right, GEN II, Size 1
Paragon 28, Inc.
P10-851-TPR1
In Commercial Distribution

  • 00889795114006 ()
P10-851-TPR1

  • Bone-coring punch, reusable

APEX 3D Total Ankle Replacement System - 00889795113993

Total Ankle, Instrument, Tibia Peg Punch, Left, GEN II, Size 6
Paragon 28, Inc.
P10-851-TPL6
In Commercial Distribution

  • 00889795113993 ()
P10-851-TPL6

  • Bone-coring punch, reusable

APEX 3D Total Ankle Replacement System - 00889795113986

Total Ankle, Instrument, Tibia Peg Punch, Left, GEN II, Size 5
Paragon 28, Inc.
P10-851-TPL5
In Commercial Distribution

  • 00889795113986 ()
P10-851-TPL5

  • Bone-coring punch, reusable

APEX 3D Total Ankle Replacement System - 00889795113979

Total Ankle, Instrument, Tibia Peg Punch, Left, GEN II, Size 4
Paragon 28, Inc.
P10-851-TPL4
In Commercial Distribution

  • 00889795113979 ()
P10-851-TPL4

  • Bone-coring punch, reusable

APEX 3D Total Ankle Replacement System - 00889795113962

Total Ankle, Instrument, Tibia Peg Punch, Left, GEN II, Size 3
Paragon 28, Inc.
P10-851-TPL3
In Commercial Distribution

  • 00889795113962 ()
P10-851-TPL3

  • Bone-coring punch, reusable

APEX 3D Total Ankle Replacement System - 00889795113955

Total Ankle, Instrument, Tibia Peg Punch, Left, GEN II, Size 2
Paragon 28, Inc.
P10-851-TPL2
In Commercial Distribution

  • 00889795113955 ()
P10-851-TPL2

  • Bone-coring punch, reusable

APEX 3D Total Ankle Replacement System - 00889795113948

Total Ankle, Instrument, Tibia Peg Punch, Left, GEN II, Size 1
Paragon 28, Inc.
P10-851-TPL1
In Commercial Distribution

  • 00889795113948 ()
P10-851-TPL1

  • Bone-coring punch, reusable

APEX 3D Total Ankle Replacement System - 00889795113931

Total Ankle, Instrument, Viper Punch, GEN II, Size 6
Paragon 28, Inc.
P10-851-TBV6
In Commercial Distribution

  • 00889795113931 ()
P10-851-TBV6

  • Bone-coring punch, reusable

APEX 3D Total Ankle Replacement System - 00889795113924

Total Ankle, Instrument, Viper Punch, GEN II, Size 5
Paragon 28, Inc.
P10-851-TBV5
In Commercial Distribution

  • 00889795113924 ()
P10-851-TBV5

  • Bone-coring punch, reusable

APEX 3D Total Ankle Replacement System - 00889795113917

Total Ankle, Instrument, Viper Punch, GEN II, Size 4
Paragon 28, Inc.
P10-851-TBV4
In Commercial Distribution

  • 00889795113917 ()
P10-851-TBV4

  • Bone-coring punch, reusable

APEX 3D Total Ankle Replacement System - 00889795113900

Total Ankle, Instrument, Viper Punch, GEN II, Size 3
Paragon 28, Inc.
P10-851-TBV3
In Commercial Distribution

  • 00889795113900 ()
P10-851-TBV3

  • Bone-coring punch, reusable

APEX 3D Total Ankle Replacement System - 00889795113894

Total Ankle, Instrument, Viper Punch, GEN II, Size 2
Paragon 28, Inc.
P10-851-TBV2
In Commercial Distribution

  • 00889795113894 ()
P10-851-TBV2

  • Bone-coring punch, reusable

APEX 3D Total Ankle Replacement System - 00889795113887

Total Ankle, Instrument, Viper Punch, GEN II, Size 1
Paragon 28, Inc.
P10-851-TBV1
In Commercial Distribution

  • 00889795113887 ()
P10-851-TBV1

  • Bone-coring punch, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795113870

Anterior Mini-Open Plate, Precision Guide Arm Base, Flat
Paragon 28, Inc.
P51-983-5005
In Commercial Distribution

  • 00889795113870 ()
P51-983-5005

  • Orthopaedic fixation implant alignment tool

Baby Gorilla®/Gorilla® Plating System - 00889795113863

Anterior Mini-Open Plate, Precision Guide Arm Base, Contoured
Paragon 28, Inc.
P51-983-5004
In Commercial Distribution

  • 00889795113863 ()
P51-983-5004

  • Orthopaedic fixation implant alignment tool

Baby Gorilla®/Gorilla® Plating System - 00889795113856

Anterior Mini-Open Plate, Joystick
Paragon 28, Inc.
P51-983-5003
In Commercial Distribution

  • 00889795113856 ()
P51-983-5003

  • Orthopaedic fixation implant alignment tool

Baby Gorilla®/Gorilla® Plating System - 00889795113849

Anterior Mini-Open Plate, Lateral Precision Guide, Tibiotalar Joint
Paragon 28, Inc.
P51-983-5002
In Commercial Distribution

  • 00889795113849 ()
P51-983-5002

  • Orthopaedic fixation implant alignment tool

Baby Gorilla®/Gorilla® Plating System - 00889795113832

Anterior Mini-Open Plate, Medial Precision Guide, Tibiotalar Joint
Paragon 28, Inc.
P51-983-5001
In Commercial Distribution

  • 00889795113832 ()
P51-983-5001

  • Orthopaedic fixation implant alignment tool

Baby Gorilla®/Gorilla® Plating System - 00889795112309

Lateral Span Plate, Flat, Standard, Left, 15-Hole, TiA
Paragon 28, Inc.
P53-422-L201
In Commercial Distribution

  • 00889795112309 ()
P53-422-L201

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795112293

Anterior Span Plate, Flat, Long, Right, 08-Hole, TiA
Paragon 28, Inc.
P53-421-R202
In Commercial Distribution

  • 00889795112293 ()
P53-421-R202

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795112286

Anterior Span Plate, Flat, Long, Left, 08-Hole, TiA
Paragon 28, Inc.
P53-421-L202
In Commercial Distribution

  • 00889795112286 ()
P53-421-L202

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795112279

Anterior Span Plate, Flat, Standard, Right, 08-Hole, TiA
Paragon 28, Inc.
P53-421-R201
In Commercial Distribution

  • 00889795112279 ()
P53-421-R201

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795112262

Anterior Span Plate, Flat, Standard, Left, 08-Hole, TiA
Paragon 28, Inc.
P53-421-L201
In Commercial Distribution

  • 00889795112262 ()
P53-421-L201

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795112255

Posterior Straddle Plate, TTC, Flat, Long, Right, 16-Hole, TiA
Paragon 28, Inc.
P53-413-R212
In Commercial Distribution

  • 00889795112255 ()
P53-413-R212

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795112248

Posterior Straddle Plate, TTC, Flat, Long, Left, 16-Hole, TiA
Paragon 28, Inc.
P53-413-L212
In Commercial Distribution

  • 00889795112248 ()
P53-413-L212

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
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