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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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Horizon 24 Centrifuge, Fisher - 00810052860398

General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-284-018-000
In Commercial Distribution

  • 00810052860398 ()
00-284-018-000

  • General-purpose centrifuge IVD

DASH Flex 24, Drucker - 00810052860060

General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-184-009-000
In Commercial Distribution

  • 00810052860060 ()
00-184-009-000

  • General-purpose centrifuge IVD

Horizon 24 Centrifuge, MarketLab - 00810052863269

General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-284-148-000
In Commercial Distribution

  • 00810052863269 ()
00-284-148-000

  • General-purpose centrifuge IVD

Horizon 24 Centrifuge, Ascend - 00810052862644

General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-284-051-000
In Commercial Distribution

  • 00810052862644 ()
00-284-051-000

  • General-purpose centrifuge IVD

Horizon 24 Centrifuge, Woodley - 00810052862637

General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-284-038-000
In Commercial Distribution

  • 00810052862637 ()
00-284-038-000

  • General-purpose centrifuge IVD

Horizon 24 Centrifuge, Spectra - 00810052862620

General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-284-035-000
In Commercial Distribution

  • 00810052862620 ()
00-284-035-000

  • General-purpose centrifuge IVD

Horizon 24 Centrifuge, Clarion - 00810052860459

General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-284-204-000
In Commercial Distribution

  • 00810052860459 ()
00-284-204-000

  • General-purpose centrifuge IVD

Horizon 24 Centrifuge, CareDx - 00810052860428

General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-284-089-000
In Commercial Distribution

  • 00810052860428 ()
00-284-089-000

  • General-purpose centrifuge IVD

Horizon 24 Centrifuge, Davita - 00810052860381

General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-284-008-000
In Commercial Distribution

  • 00810052860381 ()
00-284-008-000

  • General-purpose centrifuge IVD

Horizon 24 Flex, Drucker - 00810052860039

General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-384-009-000
In Commercial Distribution

  • 00810052860039 ()
00-384-009-000

  • General-purpose centrifuge IVD

FLOCAP, MEDLINE 24 PK - 20817770020817

No Description
MAXTEC, LLC
R500P21-001
Not in Commercial Distribution

  • 20817770020817 ()


  • Exhaled-gas oesophageal intubation detector

SuperBall 24 degrees Up - 00850000630024

The SuperBall™ Meniscal Repair System 24 Up is a single-patient and single-use device for repair procedures in the lateral and medial meniscus and for meniscal implant fixation. The SuperBall™ System is provided EtO sterile.
ARCURO MEDICAL LTD
A
In Commercial Distribution

  • 00850000630024 ()
SBD-SB-12-024

  • Polyester suture, non-bioabsorbable, multifilament

EverFlo - 00606959032750

EVERFLO w/O2 Percentage Indicator, 120V US, BRAZIL
Respironics, Inc.
EVERFLO w/O2 Percentage Indicator, 120V US, BR
In Commercial Distribution

  • 00606959032750 ()
1020002BR

  • Stationary oxygen concentrator

PillCam - 07290110361167

PillCam™ WS, v9 USA
Given Imaging, Inc.
FGS-0674
In Commercial Distribution

  • 07290110361167 ()


  • Video capsule endoscopy system application software

OSADA EXL-M40 - 04580406860478

No Description
OSADA ELECTRIC CO.,LTD.
EXL-M40
In Commercial Distribution

  • 04580406860478 ()
3223

  • Dental laboratory power tool system
  • Line-powered dental drilling system
  • Dental power tool system, line-powered

OSADA XL-230 - 04580406860461

No Description
OSADA ELECTRIC CO.,LTD.
XL-230
In Commercial Distribution

  • 04580406860461 ()
3192

  • Dental power tool system, line-powered
  • Dental laboratory power tool system
  • Line-powered dental drilling system

3M™ Nexcare™ - 30051141994971

Nexcare™ Foot Protection Tape, FPT-05, 0 x 0 (0 x 0)
3M COMPANY
FPT-05
In Commercial Distribution

  • 50051141994975 ()
  • 30051141994971 ()
  • 00051141994970 ()
FPT-05

  • Hypoallergenic skin adhesive tape

PEDIGUARD THREADED - 03662674000464

No Description
SPINEGUARD
DSG Threaded Shaft A LK - Ø4.5mm
In Commercial Distribution

  • 03662674000464 ()
D1TA1007

  • Manual surgical rotary handpiece, reusable

PEDIGUARD THREADED - 03662674000457

No Description
SPINEGUARD
DSG Threaded Shaft A LK - Ø5.5mm
In Commercial Distribution

  • 03662674000457 ()
D1TA1001

  • Manual surgical rotary handpiece, reusable

PEDIGUARD THREADED - 03662674000365

No Description
SPINEGUARD
DSG Threaded Shaft F - Ø4.0mm
In Commercial Distribution

  • 03662674000365 ()
D1TA0006

  • Manual surgical rotary handpiece, reusable

PEDIGUARD THREADED - 03662674000358

No Description
SPINEGUARD
DSG Threaded Shaft K - Ø5.5mm
In Commercial Distribution

  • 03662674000358 ()
D1TA0014

  • Manual surgical rotary handpiece, reusable

PEDIGUARD THREADED - 03662674000341

No Description
SPINEGUARD
DSG Threaded Shaft K - Ø4.5mm
In Commercial Distribution

  • 03662674000341 ()
D1TA0013

  • Manual surgical rotary handpiece, reusable

PEDIGUARD THREADED - 03662674000327

No Description
SPINEGUARD
DSG Threaded Shaft B - Ø4.5mm
In Commercial Distribution

  • 03662674000327 ()
D1TA0011

  • Manual surgical rotary handpiece, reusable

PEDIGUARD THREADED - 03662674000310

No Description
SPINEGUARD
DSG Sleeve #2
In Commercial Distribution

  • 03662674000310 ()
D1ST0002

  • Orthopaedic implantation sleeve, reusable

PEDIGUARD THREADED - 03662674000303

No Description
SPINEGUARD
DSG Threaded Shaft J - Ø4.5mm
In Commercial Distribution

  • 03662674000303 ()
D1TA0010

  • Manual surgical rotary handpiece, reusable

PEDIGUARD THREADED - 03662674000297

No Description
SPINEGUARD
DSG Threaded Shaft H - Ø5.5mm
In Commercial Distribution

  • 03662674000297 ()
D1TA0009

  • Manual surgical rotary handpiece, reusable

PEDIGUARD THREADED - 03662674000280

No Description
SPINEGUARD
DSG Threaded Shaft G - Ø5.0mm
In Commercial Distribution

  • 03662674000280 ()
D1TA0008

  • Manual surgical rotary handpiece, reusable

PEDIGUARD THREADED - 03662674000273

No Description
SPINEGUARD
DSG Threaded Shaft A - Ø4.5mm
In Commercial Distribution

  • 03662674000273 ()
D1TA0007

  • Manual surgical rotary handpiece, reusable

PEDIGUARD THREADED - 03662674000266

No Description
SPINEGUARD
DSG Technology Instrument Set - Lid
In Commercial Distribution

  • 03662674000266 ()
D1TT2001

  • Instrument tray, reusable

PEDIGUARD THREADED - 03662674000259

No Description
SPINEGUARD
DSG Technology Instrument Set - Base
In Commercial Distribution

  • 03662674000259 ()
D1TT1001

  • Instrument tray, reusable

PEDIGUARD THREADED - 03662674000242

No Description
SPINEGUARD
DSG Sleeve #1
In Commercial Distribution

  • 03662674000242 ()
D1ST0001

  • Orthopaedic implantation sleeve, reusable

PEDIGUARD THREADED - 03662674000235

No Description
SPINEGUARD
DSG Ratcheting Handle A
In Commercial Distribution

  • 03662674000235 ()
D1RH0001

  • Manual surgical rotary handpiece, reusable

PEDIGUARD THREADED - 03662674000228

No Description
SPINEGUARD
DSG Threaded Shaft C - Ø5.5mm
In Commercial Distribution

  • 03662674000228 ()
D1TA0003

  • Manual surgical rotary handpiece, reusable

PEDIGUARD THREADED - 03662674000211

No Description
SPINEGUARD
DSG Threaded Shaft B - Ø5.5mm
In Commercial Distribution

  • 03662674000211 ()
D1TA0002

  • Manual surgical rotary handpiece, reusable

PEDIGUARD THREADED - 03662674000204

No Description
SPINEGUARD
DSG Threaded Shaft A - Ø5.5mm
In Commercial Distribution

  • 03662674000204 ()
D1TA0001

  • Manual surgical rotary handpiece, reusable

CANNULATED PEDIGUARD - 03662674000167

No Description
SPINEGUARD
CANNULATES PEDIGUARD CANNULA 120mm
In Commercial Distribution

  • 03662674000167 ()

  • Length: 120 Millimeter
P2CN1110

  • Bone awl, reusable

CANNULATED PEDIGUARD - 03662674000143

No Description
SPINEGUARD
CANNULATED PEDIGUARD STARTER STYLET - TROCAR 120mm
In Commercial Distribution

  • 03662674000143 ()

  • Length: 120 Millimeter
P2ST1160

  • Bone awl, reusable

CANNULATED PEDIGUARD - 03662674000136

No Description
SPINEGUARD
CANNULATED PEDIGUARD STARTER STYLET - BEVEL 120mm
In Commercial Distribution

  • 03662674000136 ()

  • Length: 120 Millimeter
P2ST1150

  • Bone awl, reusable

CANNULATED PEDIGUARD - 03662674000105

No Description
SPINEGUARD
CANNULATED PEDIGUARD STARTER STYLET - TROCAR
In Commercial Distribution

  • 03662674000105 ()
P2ST1060

  • Bone awl, reusable

CANNULATED PEDIGUARD - 03662674000099

No Description
SPINEGUARD
CANNULATED PEDIGUARD STARTER STYLET - BEVEL
In Commercial Distribution

  • 03662674000099 ()
P2ST1050

  • Bone awl, reusable
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