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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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Interspinous Plate System - 00815362022436

All In One Inserter
PRECISION SPINE, INC.
29-1000
In Commercial Distribution

  • 00815362022436 ()
29-1000

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Integra® XT - 10381780368878

In situ Poly inserter
Ascension Orthopedics, Inc.
MJU940T
In Commercial Distribution

  • 10381780368878 ()


  • Joint prosthesis implantation kit, reusable

Phonak - 07613275726662

Phonak Brio 3 I-N
Sonova AG
063-0484-01
In Commercial Distribution

  • 07613275726662 ()
063-0484-01

  • Air-conduction hearing aid, canal

Aligned Medical Solutions - B098AMS129470

IN HOUSE OCULAR PACK
Aligned Medical Solutions
AMS12947
In Commercial Distribution

  • B098AMS129471 ()
  • B098AMS129470 ()
AMS12947

  • Ophthalmic surgical procedure kit, non-medicated, single-use

Aligned Medical Solutions - B098AMS12947A0

IN HOUSE OCULAR PACK
Aligned Medical Solutions
AMS12947A
In Commercial Distribution

  • B098AMS12947A1 ()
  • B098AMS12947A0 ()
AMS12947A

  • Ophthalmic surgical procedure kit, non-medicated, single-use

Phonak - 07613275560709

Phonak Brio 2 I-N
Sonova AG
063-0248-01
In Commercial Distribution

  • 07613275560709 ()
063-0248-01

  • Air-conduction hearing aid, canal

RETRACTOR - 00888118008534

HIP, RUIZ, TOE IN
KLS-Martin L.P.
04-101-01-07
In Commercial Distribution

  • 00888118008534 ()

  • 20 CM


  • Self-retaining surgical retractor, reusable

AVS Anchor-L - 07613252602835

ALL IN ONE GUIDE
Stryker Corporation
48992020
Not in Commercial Distribution

  • 07613252602835 ()

  • Height: 20.0 Millimeter
48992020

  • Orthopaedic fixation implant alignment tool

AVS Anchor-L - 07613252602828

ALL IN ONE GUIDE
Stryker Corporation
48992018
Not in Commercial Distribution

  • 07613252602828 ()

  • Height: 18.0 Millimeter
48992018

  • Orthopaedic fixation implant alignment tool

AVS Anchor-L - 07613252602804

ALL IN ONE GUIDE
Stryker Corporation
48992014
Not in Commercial Distribution

  • 07613252602804 ()

  • Height: 14.0 Millimeter
48992014

  • Orthopaedic fixation implant alignment tool

AVS Anchor-L - 07613252602781

ALL IN ONE GUIDE
Stryker Corporation
48992010
Not in Commercial Distribution

  • 07613252602781 ()

  • Height: 10.0 Millimeter
48992010

  • Orthopaedic fixation implant alignment tool

AVS Anchor-L - 07613252602811

ALL IN ONE GUIDE
Stryker Corporation
48992016
Not in Commercial Distribution

  • 07613252602811 ()

  • Height: 16.0 Millimeter
48992016

  • Orthopaedic fixation implant alignment tool

AVS Anchor-L - 07613252602798

ALL IN ONE GUIDE
Stryker Corporation
48992012
Not in Commercial Distribution

  • 07613252602798 ()

  • Height: 12.0 Millimeter
48992012

  • Orthopaedic fixation implant alignment tool

Procedure Products Lines - B160MF241

LINE, MALE/FEMALE-24 IN.
PROCEDURE PRODUCTS, INC.
MF-24
In Commercial Distribution

  • B160MF241 ()


  • Intravenous line recessed-needle connector

RADIUS - 07613327276237

IN SITU BENDER LEFT
Stryker Corporation
486619150
Not in Commercial Distribution

  • 07613327276237 ()
486619150

  • Manual orthopaedic bender, reusable

N/A - 00889095139846

In Situ Bender, Right
GLOBUS MEDICAL, INC.
602.511
In Commercial Distribution

  • 00889095139846 ()


  • Manual orthopaedic bender, reusable

N/A - 00889095139839

In Situ Bender, Left
GLOBUS MEDICAL, INC.
602.510
In Commercial Distribution

  • 00889095139839 ()


  • Manual orthopaedic bender, reusable

The Better Bunion - G2710110000160

20° in Guide, Right
Mios Marketing, LLC
Lapidus
In Commercial Distribution

  • G2710110000160 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable

Cora - X002US3067

Disc, Amazon in Tins
Cora
10Disc-003
Not in Commercial Distribution

  • X002US3067 ()


  • Menstrual cup, non-latex, reusable

Sklar® - 10649111239595

ABBEY NH 5 IN
SKLAR CORPORATION
97-894
In Commercial Distribution

  • 10649111239595 ()


  • Suturing needle holder, reusable

NA - 10603295148845

STERILE CASE 5 IN
DEPUY ORTHOPAEDICS, INC.
2601-04-000
In Commercial Distribution

  • 10603295148845 ()
260104000

  • Device sterilization/disinfection container, reusable

NA - 10603295148821

STERILIZATION CASE 7 IN
DEPUY ORTHOPAEDICS, INC.
2601-02-000
In Commercial Distribution

  • 10603295148821 ()
260102000

  • Device sterilization/disinfection container, reusable

PULSAVAC® - 00889024375109

Power Supply, IN/ZA
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
00-5150-350-08
In Commercial Distribution

  • 00889024375109 ()
00-5150-350-08

  • Surgical/orthopaedic lavage system power supply

Sklar - 10649111431074

SCHUMACHER STERNUM SHEARS8.25 IN
SKLAR CORPORATION
55-1697
In Commercial Distribution

  • 10649111431074 ()


  • Rib rongeur

Omnicap - 08056646507535

Forage cap in Sontara
OMNIA SRL
10.M0006.00
In Commercial Distribution

  • 08056646507542 ()
  • 08056646507535 ()


  • Surgical cap, single-use

Xenon - 00190376264134

RIGHT IN SITU BENDER
ALPHATEC SPINE, INC.
22CIN06-G
Not in Commercial Distribution

  • 00190376264134 ()


  • Manual orthopaedic bender, reusable

Xenon - 00190376264127

LEFT IN SITU BENDER
ALPHATEC SPINE, INC.
22CIN06-D
Not in Commercial Distribution

  • 00190376264127 ()


  • Manual orthopaedic bender, reusable

Inertia® CONNEXX™ Modular Pedicle Screw System - 00889929050293

T-25 In Situ Driver
NEXXT SPINE, LLC
I20-10-02
In Commercial Distribution

  • 00889929050293 ()


  • General internal orthopaedic fixation system implantation kit

Inertia® MIS Pedicle Screw System - 00889929018699

In Situ Driver, T15
NEXXT SPINE, LLC
I10-14-15
In Commercial Distribution

  • 00889929018699 ()


  • General internal orthopaedic fixation system implantation kit

Dermacea - 10884521065291

Dressing in Strippable Envelope
Cardinal Health, Inc.
8886834200
Not in Commercial Distribution

  • 20884521065298 ()
  • 10884521065291 ()
  • 30884521065295 ()

  • Length: 12 Inch
  • Width: 8 Inch
8886834200

  • Wound-nonadherent dressing, permeable, non-antimicrobial

PUMA-G System™ - 10860312001532

External Magnet in Case
Coaptech, Inc.
0010080
In Commercial Distribution

  • 00860312001542 ()
  • 10860312001532 ()
  • 00860312001535 ()
0010090

  • Ultrasound-guided gastrostomy system magnet

PUMA-G System™ - 10850026037132

External Magnet in Case
Coaptech, Inc.
0010323
In Commercial Distribution

  • 10850026037132 ()
  • 00850026037135 ()
  • 00850026037142 ()
0010366

  • Ultrasound-guided gastrostomy system magnet

OVERWATCH - 00840916135782

IN SITU BENDER - RIGHT
SPINAL ELEMENTS
AISB-0019HCR
In Commercial Distribution

  • 00840916135782 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

OVERWATCH - 00840916135775

IN SITU BENDER - LEFT
SPINAL ELEMENTS
AISB-0019HCL
In Commercial Distribution

  • 00840916135775 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

OVERWATCH - 00840916148089

IN SITU BENDER 5.5MM
SPINAL ELEMENTS
AISB-0019HC
In Commercial Distribution

  • 00840916148089 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

Rhythmia™ Mapping System - 08714729842002

Breakout Box B In
BOSTON SCIENTIFIC CORPORATION
M004RH12000
In Commercial Distribution

  • 08714729842002 ()


  • Cardiac mapping system

Rhythmia™ Mapping System - 08714729841982

Breakout Box A In
BOSTON SCIENTIFIC CORPORATION
M004RH11000
In Commercial Distribution

  • 08714729841982 ()


  • Cardiac mapping system

MONT BLANC - 03663422600561

Bender in situ, left
SPINEWAY
1
In Commercial Distribution

  • 03663422600561 ()

  • Left
037BIL1

  • Orthopaedic surgical procedure kit, non-medicated, reusable

MONT BLANC - 03663422600554

Bender in situ, right
SPINEWAY
1
In Commercial Distribution

  • 03663422600554 ()

  • Right
036BIR1

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Marina Medical - 00840306827754

Iris Hook 12 in.
MARINA MEDICAL INSTRUMENTS, INC.
295-101XL
In Commercial Distribution

  • 00840306827754 ()

  • Length: 12 Inch
295-101XL

  • Assistive dressing/undressing hook/stick

BacterioScan 216Dx System - B9090051

Disposable used in system
BACTERIOSCAN, INC.
Clear Cartridge - 4 Well Tray
In Commercial Distribution

  • B90900511 ()
  • B9090051 ()


  • Microbial incubator/imaging system IVD

PASS LP - 03613720210801

LEFT IN SITU BENDER
MEDICREA INTERNATIONAL
A01170602
Not in Commercial Distribution

  • 03613720210801 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

PASS LP - 03613720210795

RIGHT IN SITU BENDER
MEDICREA INTERNATIONAL
A01170601
Not in Commercial Distribution

  • 03613720210795 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

PASS XS - 03613720247012

IN SITU BENDER, LEFT
MEDICREA INTERNATIONAL
A19024502
Not in Commercial Distribution

  • 03613720247012 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

PASS XS - 03613720247005

IN SITU BENDER, RIGHT
MEDICREA INTERNATIONAL
A19024501
Not in Commercial Distribution

  • 03613720247005 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

LEONE SPA - 08033707066842

RADIO-OPAQUE SEPARATORS IN MODULES
LEONE SPA
K6378-00
In Commercial Distribution

  • 08033707066842 ()
K6378-00

  • Orthodontic inter-arch elastic band

CARDINAL HEALTH - 10810010891430

Lab In A Pouch
Cardinal Health 200, LLC
HH8000
In Commercial Distribution

  • 10810010891430 ()
HH8000

  • Evacuated blood collection tube IVD, K2EDTA

Entrada ™ - 08714729950691

Needle 15cm (6.0 in)
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-4220-60
In Commercial Distribution

  • 08714729950691 ()

  • 15 cm Length


  • Analgesic spinal cord electrical stimulation system

RHYTHMIA HDx™ - 08714729938514

ECG IN Cable (Trunk)
BOSTON SCIENTIFIC CORPORATION
M004RA5010I0
In Commercial Distribution

  • 08714729938514 ()


  • Electrocardiographic lead set, reusable

RHYTHMIA HDx™ - 08714729938507

ECG IN Cable (Trunk)
BOSTON SCIENTIFIC CORPORATION
M004RA5010A0
In Commercial Distribution

  • 08714729938507 ()


  • Electrocardiographic lead set, reusable
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