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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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Disc Prep - 10889981103569

O'Brien Currette, 18"OAL,9"Handle
Seaspine Orthopedics Corporation
06-40-0411
In Commercial Distribution

  • 10889981103569 ()

  • 18", 9"
06-40-0411

  • Poliovirus total antibody (serotypes PV1-PV3) IVD, kit, complement fixation test (CFT)

Disc Prep - 10889981103545

Ring Currette #4, 18"OAL, 9"Handle
Seaspine Orthopedics Corporation
06-40-0354
In Commercial Distribution

  • 10889981103545 ()

  • 18", 9"
06-40-0354

  • Poliovirus total antibody (serotypes PV1-PV3) IVD, kit, complement fixation test (CFT)

MAESTRO TOTAL WRIST - 00880304439207

No Description
Biomet Orthopedics, LLC
180153
In Commercial Distribution

  • 00880304439207 ()

  • 9 MM
180153

  • Total wrist radius prosthesis

Disc Prep - 10889981103552

O'Brien Currette, 18" OAL, 9" Handle
Seaspine Orthopedics Corporation
06-40-0408
In Commercial Distribution

  • 10889981103552 ()

  • 18", 9"
06-40-0408

  • Poliovirus total antibody (serotypes PV1-PV3) IVD, kit, complement fixation test (CFT)

Disc Prep - 10889981103538

Ring Currette #2, 18"OAL, 9" Handle
Seaspine Orthopedics Corporation
06-40-0352
In Commercial Distribution

  • 10889981103538 ()

  • 18", 9"
06-40-0352

  • Poliovirus total antibody (serotypes PV1-PV3) IVD, kit, complement fixation test (CFT)

ACRYSOF ULTRASERT - 00380652358057

AcrySof(R) IQ ASPHERIC IOL SP ACRYLIC FOLDABLELENS wUltraSert(TM) DELIVERY SYSTEM UV wBLUE LIGHT FILTER. 13.0mm LENGTH 6.0mm ANTERIORASYMMETRIC BICONVEX OPTIC PLANAR HAPTICS.
Alcon Laboratories, Inc.
AU00T0
In Commercial Distribution

  • 00380652358057 ()

  • Diopter 9
AU00T0.090

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® - 00380652332446

AcrySof(R) ASPHERIC IOL, SINGLE-PIECE ACRYLICFOLDABLE POSTERIOR CHAMBER LENS,UV-ABSORBING, 13.0mm LENGTH, 6.0mm ANTERIORASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS.
Alcon Laboratories, Inc.
SA60WF
In Commercial Distribution

  • 00380652332446 ()

  • Diopter 9
SA60WF.090

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® RESTOR® - 00380652307529

AcrySof(R) IQ ReSTOR(R) MULTIFOCAL IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm APODIZEDDIFFRACTIVE ASPHERIC OPTIC.
Alcon Laboratories, Inc.
SV25T0
Not in Commercial Distribution

  • 00380652307529 ()

  • Diopter 9


  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® - 00380652279406

AcrySof(R) IQ TORIC ASTIGMATISM IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm BICONVEX TORICASPHERIC OPTIC, 6.00 D CYLINDER.
Alcon Laboratories, Inc.
SN6AT9
Not in Commercial Distribution

  • 00380652279406 ()

  • Diopter 9
SN6AT9U090

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® - 00380652277822

AcrySof(R) IQ TORIC ASTIGMATISM IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm BICONVEX TORICASPHERIC OPTIC, 5.25 D CYLINDER.
Alcon Laboratories, Inc.
SN6AT8
Not in Commercial Distribution

  • 00380652277822 ()

  • Diopter 9
SN6AT8U090

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® - 00380652274647

AcrySof(R) IQ TORIC ASTIGMATISM IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm BICONVEX TORICASPHERIC OPTIC, 3.75 D CYLINDER.
Alcon Laboratories, Inc.
SN6AT6
Not in Commercial Distribution

  • 00380652274647 ()

  • Diopter 9
SN6AT6U090

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® - 00380652276238

AcrySof(R) IQ TORIC ASTIGMATISM IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm BICONVEX TORICASPHERIC OPTIC, 4.50 D CYLINDER.
Alcon Laboratories, Inc.
SN6AT7
Not in Commercial Distribution

  • 00380652276238 ()

  • Diopter 9
SN6AT7U090

  • Posterior-chamber intraocular lens, pseudophakic

MOBIS - 04047844045190

An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
SIGNUS Medizintechnik GmbH
Graft loading platform
In Commercial Distribution

  • 04047844045190 ()

  • 9/11mm
B026AH

  • Orthopaedic surgical procedure kit, non-medicated, reusable

ATHLET - 04047844044704

An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
SIGNUS Medizintechnik GmbH
Inserter plate
In Commercial Distribution

  • 04047844044704 ()

  • 8/9
AT0007

  • Orthopaedic surgical procedure kit, non-medicated, reusable

implaFit® trial neck K12/14 lat. stem - 04048844525798

No Description
implantcast GmbH
80084089
In Commercial Distribution

  • 04048844525798 ()

  • 8+9


  • Femoral head prosthesis trial

implaFit® trial neck K12/14 std. stem - 04048844525583

No Description
implantcast GmbH
80083089
In Commercial Distribution

  • 04048844525583 ()

  • 8+9


  • Femoral head prosthesis trial

Uni FB joint gap check resection - 04048844544560

No Description
implantcast GmbH
42160386
In Commercial Distribution

  • 04048844544560 ()

  • -9/-10mm


  • Abdominal/ENT/orthopaedic surgical probe, reusable

CYLOX ST - 04047844128015

An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
SIGNUS Medizintechnik GmbH
Drill guide
In Commercial Distribution

  • 04047844128015 ()

  • Cage 9
CZ0003-09

  • Orthopaedic surgical procedure kit, non-medicated, reusable

BethaLoc® - 04048844239480

stem cementless lateralized HA
implantcast GmbH
87001029
In Commercial Distribution

  • 04048844239480 ()

  • sz. 9


  • Press-fit femoral stem prosthesis

BethaLoc® - 04048844239459

stem cementless standard HA
implantcast GmbH
87001009
In Commercial Distribution

  • 04048844239459 ()

  • sz. 9


  • Press-fit femoral stem prosthesis

Actinia® - 04048844153410

hip stem with collar cementless standard
implantcast GmbH
80040409
In Commercial Distribution

  • 04048844153410 ()

  • sz. 9


  • Press-fit femoral stem prosthesis

Actinia® - 04048844153359

hip stem with collar cementless lateralized
implantcast GmbH
80040509
In Commercial Distribution

  • 04048844153359 ()

  • sz. 9


  • Press-fit femoral stem prosthesis

Actinia® - 04048844152802

hip stem cementless standard
implantcast GmbH
80040009
In Commercial Distribution

  • 04048844152802 ()

  • sz. 9


  • Press-fit femoral stem prosthesis

Actinia® - 04048844152741

hip stem cementless lateralized
implantcast GmbH
80040109
In Commercial Distribution

  • 04048844152741 ()

  • sz. 9


  • Press-fit femoral stem prosthesis

Novation Element - 10885862249265

BROACH, NOVATION ELEMENT, SIZE 9
Exactech, Inc.
165-10-09
In Commercial Distribution

  • 10885862249265 ()

  • SIZE 9
165-10-09

  • Orthopaedic broach

Novation - 10885862239662

TEMPLATE, STEM, SIZE 9
Exactech, Inc.
161-95-50-09
In Commercial Distribution

  • 10885862239662 ()

  • SIZE 9
161-95-50-09

  • Surgical implant template, reusable

Novation - 10885862239488

TEMPLATE, STEM, SIZE 9
Exactech, Inc.
161-95-20-09
In Commercial Distribution

  • 10885862239488 ()

  • SIZE 9
161-95-20-09

  • Surgical implant template, reusable

Novation Element - 10885862204127

NV ELEM RO NT X/O SZ 9 NECK TRIAL
Exactech, Inc.
165-12-09
In Commercial Distribution

  • 10885862204127 ()

  • SIZE 9
165-12-09

  • Femoral stem prosthesis trial

Novation Element - 10885862204066

NV ELEM RO NT S/O SZ 9 NECK TRIAL
Exactech, Inc.
165-11-09
In Commercial Distribution

  • 10885862204066 ()

  • SIZE 9
165-11-09

  • Femoral stem prosthesis trial

Novation - 10885862034830

TAPERED STEM TRIAL EXT OFFSET SZ 9
Exactech, Inc.
161-51-09
In Commercial Distribution

  • 10885862034830 ()

  • SIZE 9
161-51-09

  • Femoral stem prosthesis trial

NA - 10885862034731

TRIAL, STEM, TAPERED, SIZE 9
Exactech, Inc.
161-50-09
In Commercial Distribution

  • 10885862034731 ()

  • SIZE 9
161-50-09

  • Femoral stem prosthesis trial

Novation - 10885862034557

TRIAL, NECK, HIGH OFFSET, SIZE 9
Exactech, Inc.
161-23-09
In Commercial Distribution

  • 10885862034557 ()

  • SIZE 9
161-23-09

  • Femoral stem prosthesis trial

Novation - 10885862034465

TRIAL, NECK, STANDARD OFFSET, SIZE 9
Exactech, Inc.
161-22-09
In Commercial Distribution

  • 10885862034465 ()

  • SIZE 9
161-22-09

  • Femoral stem prosthesis trial

NA - 10885862034328

STD OFFSET NECK TRIAL SZ 9
Exactech, Inc.
161-20-09
In Commercial Distribution

  • 10885862034328 ()

  • SIZE 9
161-20-09

  • Femoral stem prosthesis trial

Novation - 10885862033468

BROACH, TAPERED, SIZE 9
Exactech, Inc.
161-02-09
In Commercial Distribution

  • 10885862033468 ()

  • SIZE 9
161-02-09

  • Orthopaedic broach

DEBAKEY COARCTATION CLAMP - 00192896002869

DEBAKEY COARCTATION CLAMP STRAIGHT
SONTEC INSTRUMENTS, INC.
2100-630
In Commercial Distribution


  • 9 Inch


  • Surgical soft-tissue manipulation forceps, scissors-like, reusable

Alteon - 10885862514127

ALT HA S DMND BRCH SZ 9
Exactech, Inc.
191-13-09
In Commercial Distribution

  • 10885862514127 ()

  • SZ 9
191-13-09

  • Orthopaedic broach

Alteon - 10885862513847

ALT HA S COMP BRCH SZ 9
Exactech, Inc.
191-03-09
In Commercial Distribution

  • 10885862513847 ()

  • SZ 9
191-03-09

  • Orthopaedic broach

Alteon - 10885862513717

ALT HA L COMP BRCH SZ 9
Exactech, Inc.
191-02-09
In Commercial Distribution

  • 10885862513717 ()

  • SZ 9
191-02-09

  • Orthopaedic broach

Vantage - 10885862546333

FCT GAP CHECK TL SZ 1-2
Exactech, Inc.
351-10-21
In Commercial Distribution

  • 10885862546333 ()

  • SIZE 9
351-10-21

  • Ankle prosthesis trial, reusable

TUMARK Flex - 04250195602213

No Description
SOMATEX Medical Technologies GmbH
271576
Not in Commercial Distribution

  • 04250195604682 ()
  • 04250195602213 ()

  • 9 Gauge
271576

  • Radiological image marker, implantable

ACRYSOF, IQ RESTOR - 00380652270403

Acrysof IQ ReStor Multifocal Toric IOL, STERILE UV and Blue Light Filtering Acrylic Foldable; Apodized Diffractive Aspheric Multifocal Toric Posterior Chamber Intraocular Lens; IOL Cylinder Power 2.31
Alcon Laboratories, Inc.
SND1T4
Not in Commercial Distribution

  • 00380652270403 ()

  • Diopter 9
SND1T4U090

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® - 00380652250771

AcrySof(R) IQ TORIC ASTIGMATISM IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm BICONVEX TORICASPHERIC OPTIC, 3.00 D CYLINDER.
Alcon Laboratories, Inc.
SN6AT5
In Commercial Distribution

  • 00380652250771 ()

  • Diopter 9
SN6AT5.090

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® - 00380652250207

AcrySof(R) IQ TORIC ASTIGMATISM IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm BICONVEX TORICASPHERIC OPTIC, 2.25 D CYLINDER.
Alcon Laboratories, Inc.
SN6AT4
In Commercial Distribution

  • 00380652250207 ()

  • Diopter 9
SN6AT4.090

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® - 00380652249676

AcrySof(R) IQ TORIC ASTIGMATISM IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm BICONVEX TORICASPHERIC OPTIC, 1.50 D CYLINDER.
Alcon Laboratories, Inc.
SN6AT3
In Commercial Distribution

  • 00380652249676 ()

  • Diopter 9
SN6AT3.090

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® ACRYSERT® - 00380652248990

AcrySof(R) IQ ASPHERIC IOL, SP ACRYLIC FOLDABLELENS, w/AcrySert(R) DELIVERY SYSTEM, UV w/BLUELIGHT FILTER, 13.0mm LENGTH, 6.0mm ANTERIORASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS.
Alcon Laboratories, Inc.
SN6CWS
Not in Commercial Distribution

  • 00380652248990 ()

  • Diopter 9
SN6CWS.090

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® Monoflex® - 00380650698315

AcrySof(R) SOFT ACRYLIC MULTIPIECE STERILEPCL (IOL/PC), 13.0mm LENGTH, 6.5mm BICONVEXOPTIC, 10-DEGREE Monoflex(TM*) HAPTICS. *REG. U.S. PAT. & TM OFF.
Alcon Laboratories, Inc.
MA50BM
In Commercial Distribution

  • 00380650698315 ()

  • Diopter 9
MA50BM.090

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® - 00380650130082

AcrySof(R) Natural SINGLE-PIECE ACRYLICFOLDABLE IOL, UV WITH BLUE LIGHT FILTER,POSTERIOR CHAMBER LENS (IOL/PC), 13.0mm LENGTH,6.0mm BICONVEX OPTIC, PLANAR HAPTICS.
Alcon Laboratories, Inc.
SN60AT
In Commercial Distribution

  • 00380650130082 ()

  • Diopter 9
SN60AT.090

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® IQ RESTOR ® Monoflex® - 00380652262835

AcrySof(R) IQ ReSTOR(R) APODIZED DIFFRACTIVEMULTIPIECE STERILE PCL(IOL/PC) 13.0mm LENGTH 6.0mm OPTIC 10-DEGREE Monoflex(TM*) HAPTICS.*REG. U.S. PAT. & TM OFF.
Alcon Laboratories, Inc.
MN6AD1
In Commercial Distribution

  • 00380652262835 ()

  • Diopter 9


  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® IQ RESTOR® - 00380652249591

AcrySof(R) IQ ReSTOR(R) MULTIFOCAL IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm APODIZEDDIFFRACTIVE ASPHERIC OPTIC.
Alcon Laboratories, Inc.
SN6AD1
Not in Commercial Distribution

  • 00380652249591 ()

  • Diopter 9


  • Posterior-chamber intraocular lens, pseudophakic
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