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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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Total Ankle Replacement System, Poly Trial Insert, Size 1, 16mm
Paragon 28, Inc.
P10-930-I116
In Commercial Distribution

  • 00889795110497 ()
P10-930-I116

  • Surgical implant template, reusable
Total Ankle Replacement System, Poly Trial Insert, Size 1, 14mm
Paragon 28, Inc.
P10-930-I114
In Commercial Distribution

  • 00889795110480 ()
P10-930-I114

  • Surgical implant template, reusable
Silverback Gorilla, Caddy Base, Posterior Plates
Paragon 28, Inc.
P50-900-SBPOS
In Commercial Distribution

  • 00889795110442 ()
P50-900-SBPOS

  • Device sterilization/disinfection container, reusable
Precision Guide, Subtalar Joint, Guide Arm
Paragon 28, Inc.
P51-982-5101
In Commercial Distribution

  • 00889795110435 ()
P51-982-5101

  • Orthopaedic fixation implant alignment tool
Precision Guide, Tibiotalar Joint, Guide Arm
Paragon 28, Inc.
P51-982-5001
In Commercial Distribution

  • 00889795110428 ()
P51-982-5001

  • Orthopaedic fixation implant alignment tool
Posterior TTC Plate, Long, Flat, Right, 10-Hole, TiA
Paragon 28, Inc.
P53-403-R212
In Commercial Distribution

  • 00889795110411 ()
P53-403-R212

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Posterior TTC Plate, Standard, Flat, Right, 08-Hole, TiA
Paragon 28, Inc.
P53-403-R211
In Commercial Distribution

  • 00889795110404 ()
P53-403-R211

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Posterior TTC Plate, Standard, Flat, Left, 08-Hole, TiA
Paragon 28, Inc.
P53-403-L211
In Commercial Distribution

  • 00889795110381 ()
P53-403-L211

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Posterior TTC Plate, Long, Contoured, Right, 10-Hole, TiA
Paragon 28, Inc.
P53-403-R112
In Commercial Distribution

  • 00889795110374 ()
P53-403-R112

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Posterior TTC Plate, Standard, Contoured, Right, 08-Hole, TiA
Paragon 28, Inc.
P53-403-R111
In Commercial Distribution

  • 00889795110367 ()
P53-403-R111

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Posterior TTC Plate, Standard, Contoured, Left, 08-Hole, TiA
Paragon 28, Inc.
P53-403-L111
In Commercial Distribution

  • 00889795110343 ()
P53-403-L111

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Posterior TT Plate, Long, Flat, Right, 08-Hole, TiA
Paragon 28, Inc.
P53-403-R202
In Commercial Distribution

  • 00889795110336 ()
P53-403-R202

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Posterior TT Plate, Standard, Flat, Right, 06-Hole, TiA
Paragon 28, Inc.
P53-403-R201
In Commercial Distribution

  • 00889795110329 ()
P53-403-R201

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Posterior TT Plate, Long, Flat, Left, 08-Hole, TiA
Paragon 28, Inc.
P53-403-L202
In Commercial Distribution

  • 00889795110312 ()
P53-403-L202

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Posterior TT Plate, Standard, Flat, Left, 06-Hole, TiA
Paragon 28, Inc.
P53-403-L201
In Commercial Distribution

  • 00889795110305 ()
P53-403-L201

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Silverback Gorilla Lateral TTC Plate Template, Standard, Right
Paragon 28, Inc.
P54-402-R101
In Commercial Distribution

  • 00889795110282 ()
P54-402-R101

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Silverback Gorilla Lateral TTC Plate Template, Standard, Left
Paragon 28, Inc.
P54-402-L101
In Commercial Distribution

  • 00889795110251 ()
P54-402-L101

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Silverback Gorilla Anterior TT Plate Template, Standard, Right
Paragon 28, Inc.
P54-401-R101
In Commercial Distribution

  • 00889795110183 ()
P54-401-R101

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Silverback Gorilla Anterior TT Plate Template, Standard, Contoured, Left
Paragon 28, Inc.
P54-401-L101
In Commercial Distribution

  • 00889795110121 ()
P54-401-L101

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Paratrooper Caddy Base
Paragon 28, Inc.
P13-900-BASE
In Commercial Distribution

  • 00889795107602 ()
P13-900-BASE

  • Device sterilization/disinfection container, reusable
Paratrooper Caddy Lid
Paragon 28, Inc.
P13-900-ALID
In Commercial Distribution

  • 00889795107596 ()
P13-900-ALID

  • Device sterilization/disinfection container, reusable
PALM Ratcheting Driver Handle w/ AO Connect w/ Suture Cleat
Paragon 28, Inc.
P99-000-AORP
In Commercial Distribution

  • 00889795107589 ()
P99-000-AORP

  • Surgical instrument handle, non-torque-limiting
Blind Tunnel Driver Handle w/ AO Connect w/ Suture Cleat
Paragon 28, Inc.
P41-980-1000
In Commercial Distribution

  • 00889795107572 ()
P41-980-1000

  • Suturing unit, single-use
Blind-Tunnel Suture Loop Guide Rod w/ Nitinol Loop
Paragon 28, Inc.
P41-960-0030
In Commercial Distribution

  • 00889795107565 ()
P41-960-0030

  • Suturing unit, single-use
Ø7.0/8.0 Driver Sleeve
Paragon 28, Inc.
P41-942-7080
In Commercial Distribution

  • 00889795107558 ()
P41-942-7080

  • Orthopaedic implantation sleeve, reusable
Ø5.5/6.0 Driver Sleeve
Paragon 28, Inc.
P41-942-5560
In Commercial Distribution

  • 00889795107541 ()
P41-942-5560

  • Orthopaedic implantation sleeve, reusable
Ø4.5/5.0 Driver Sleeve
Paragon 28, Inc.
P41-942-4550
In Commercial Distribution

  • 00889795107534 ()
P41-942-4550

  • Orthopaedic implantation sleeve, reusable
Ø5.0 Cannulated Drill w/ Depth Markings
Paragon 28, Inc.
P41-910-5015
In Commercial Distribution

  • 00889795107152 ()
P41-910-5015

  • Cannulated surgical drill bit, reusable
Ø4.5 Cannulated Drill w/ Depth Markings
Paragon 28, Inc.
P41-910-4515
In Commercial Distribution

  • 00889795107145 ()
P41-910-4515

  • Cannulated surgical drill bit, reusable
Ø4.0 Cannulated Drill w/ Depth Markings
Paragon 28, Inc.
P41-910-4015
In Commercial Distribution

  • 00889795107138 ()
P41-910-4015

  • Cannulated surgical drill bit, reusable
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