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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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K-2oem ALT-AIRE+ - 00817012022193

On-Demand Low Air Loss Expandable Mattress System, 80"-84"-88" x 36"~39-42"-48" x 10"
KAP MEDICAL
K-2oemXMS
In Commercial Distribution

  • 00817012022193 ()
K-2oemXMS

  • Low-air-loss bed

Rumex - 00840159900901

Gills-Vannas Capsulotomy Scissors, Curved, Sharp Tips, 10.00 mm Blades, Flat Handle, Length 88 mm, Stainless Steel
RUMEX INTERNATIONAL CORP.
11-058S
In Commercial Distribution

  • 00840159900901 ()
11-058S

  • Intraocular scissors, probe-like, reusable

Rumex - 00840159905029

Gills-Vannas Capsulotomy Scissors, Straight, Sharp Tips, 10.00 mm Blades, Flat Handle, Length 88 mm, Stainless Steel
RUMEX INTERNATIONAL CORP.
11-056S
In Commercial Distribution

  • 00840159905029 ()
11-056S

  • Intraocular scissors, probe-like, reusable

InfiltraLong set consisting of: - 14048223016692

InfiltraLong set consisting of: InfiltraLong catheter 19G x 900mm with integrated metal spiral with 88 drill
Pajunk GmbH Medizintechnologie
001158-40C
Not in Commercial Distribution

  • 14048223016692 ()
  • 04048223016695 ()
001158-40C

  • Peripheral anaesthesia catheter set, non-medicated

Halyard - 30680651423024

Standard Back Table Cover, Fan Fold, 88 in. x 44 in. / 224 cm x 112 cm
O&M HALYARD, INC.
42302
In Commercial Distribution

  • 90680651423026 ()
  • 30680651423024 ()
42302NS

  • Medical equipment/instrument drape, single-use

CVS Health - 00050428619087

Waterproof Adhesive Pad, all one size, 3.5 IN x 4.5 IN (88 mm x 114 mm)
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
397239
In Commercial Distribution

  • 20050428619081 ()
  • 00050428619087 ()
  • 60050428619089 ()


  • Adhesive bandage

ARROW - 00801902075840

15 Fr. x 27 cm NextStep(R) Antegrade Hemodialysis Catheter. Long-Term Access. Catheter Length, Tip to Cuff: 27 cm
TELEFLEX INCORPORATED
IPN032569
In Commercial Distribution

  • 10801902075847 ()
  • 00801902075840 ()
  • 30801902075841 ()

  • Length: 27 Centimeter
  • Catheter Gauge: 15 French
AC-15272-XCO

  • Double-lumen haemodialysis catheter, implantable

ARROW - 00801902095961

15 Fr. x 27 cm NextStep(R) Antegrade Hemodialysis Catheter. Long-Term Access. Catheter Length, Tip to Cuff: 27 cm
TELEFLEX INCORPORATED
IPN032570
In Commercial Distribution

  • 10801902095968 ()
  • 00801902095961 ()
  • 30801902095962 ()

  • Length: 27 Centimeter
  • Catheter Gauge: 15 French
AC-15272-XCO

  • Double-lumen haemodialysis catheter, implantable

Halyard - 10680651893533

Utility Drape, 35 in. x 35 in./90 cm x 90 cm
O&M HALYARD, INC.
89353
In Commercial Distribution

  • 30680651893537 ()
  • 10680651893533 ()
89353

  • Patient surgical drape, single-use

HELMUT ZEPF - EZPF4186806SL0

CURETTE, PERIODONTIC KIRSCH SINUS 6 "SMALL", LONG SHANK, ELEV./CURETTE 90°/90°,
Helmut Zepf Medizintechnik GmbH
41.868.06SL
In Commercial Distribution

  • EZPF4186806SL0 ()
41.868.06SL

  • Periosteal elevator, reusable

HELMUT ZEPF - EZPF41868050

CURETTE, PERIODONTIC KIRSCH SINUS 5 ELEV./CURETTE 90°/90°/60° TITANIUM-ZEPF-LINE , TURQUOISE
Helmut Zepf Medizintechnik GmbH
41.868.05
In Commercial Distribution

  • EZPF41868050 ()
41.868.05

  • Periosteal elevator, reusable

ASTRA-OCT Spine System - M824A3OR409032K1

ASTRA-OCT Dia. 4mm CoCr Occipital Rod, 325mm x 90 deg (90 deg)
SPINECRAFT, LLC
A3OR-40-9032K
Not in Commercial Distribution

  • 00193082082818 ()
  • M824A3OR409032K1 ()
A3OR-40-9032K

  • Bone-screw internal spinal fixation system rod

VAPR - 10886705009398

VAPR S 90 Electrode 40 mm 90 DEGREES Suction with Integrated Handpiece
DEPUY MITEK, LLC
225370
In Commercial Distribution

  • 10886705009398 ()
225370

  • Endoscopic electrosurgical electrode, bipolar, single-use

MicroFrance® - 10381780103523

MicroFrance® Struycken 90 degree left opening cutting forceps, 90 mm length
INTEGRA MICROFRANCE
MCEN67-2
In Commercial Distribution

  • 10381780103523 ()
MCEN67-2

  • ENT soft-tissue cutting forceps

MicroFrance® - 10381780103516

MicroFrance® Struycken 90 degree right opening cutting forceps, 90 mm length
INTEGRA MICROFRANCE
MCEN67-1
In Commercial Distribution

  • 10381780103516 ()
MCEN67-1

  • ENT soft-tissue cutting forceps

Elite Bandage Strip - 00816703023099

Elite Bandage Strip, 1x3 / Elite First Aid Part Number: 560
MEDSOURCE INTERNATIONAL LLC
ELITE-17213
In Commercial Distribution

  • 00816703023105 ()
  • 00816703023099 ()
Not Applicable

  • Adhesive bandage

VTI 8 MHz TRANS-Q-TANEOUS Intraoperative Doppler Transceiver - 00817122020508

Part Number 108800, VTI 8 MHz TRANS-Q-TANEOUS Intraoperative Doppler Transceiver
VASCULAR TECHNOLOGY, INCORPORATED
108800
In Commercial Distribution

  • 00817122020508 ()
  • 00817122020638 ()
108800

  • Vascular ultrasound system control unit

07-150-02 20 MHz Mizuho Surgical Doppler Transceiver - 00817122020386

Part Number 128160, 07-150-02 20 MHz Mizuho Surgical Doppler Transceiver
VASCULAR TECHNOLOGY, INCORPORATED
128160
In Commercial Distribution

  • 00817122020386 ()
  • 00817122020652 ()
128160

  • Vascular ultrasound system control unit

VTI 20 MHz Surgical Doppler Transceiver, AC - 00817122020348

Part Number 108400-AC, VTI 20 MHz Surgical Doppler Transceiver, AC
VASCULAR TECHNOLOGY, INCORPORATED
108400-AC
In Commercial Distribution

  • 00817122020348 ()
  • 00817122020669 ()
108400-AC

  • Vascular ultrasound system control unit

VTI Remotely Operated Suction & Irrigation System - 00817122020065

PART NUMBER 106400 VTI Remotely Operated Suction & Irrigation System Device
VASCULAR TECHNOLOGY, INCORPORATED
106400
In Commercial Distribution

  • 00817122020065 ()
  • 00817122020614 ()
106400

  • Surgical irrigation/aspiration pump, reusable

Elite Shears - 00816703023310

Elite Shears, EMS, Black / Elite First Aid Part Number: 312
MEDSOURCE INTERNATIONAL LLC
ELITE-SH001B
In Commercial Distribution

  • 00816703023327 ()
  • 00816703023310 ()
Not Applicable

  • Bandage scissors, reusable

Elite Stethoscope - 00816703023198

Elite Dual-Head Steth, Black, Elite First Aid Part Number: 601
MEDSOURCE INTERNATIONAL LLC
ELITE-70031
In Commercial Distribution

  • 00816703023204 ()
  • 00816703023198 ()
Not Applicable

  • Mechanical external stethoscope

Elite Transparent Tape - 00816703023044

Elite, Transparent Tape, 1 / Elite First Aid Part Number: 4014
MEDSOURCE INTERNATIONAL LLC
ELITE-15010
In Commercial Distribution

  • 00816703023044 ()
  • 00816703023051 ()
Not Applicable

  • Dressing-fixation skin adhesive tape, non-silicone

Wellness - 00819835023425

Wellness - Dilator Kit - Purple Part Number: BL-444111 Material Type: Silicone
Blush Novelties
Wellness - Dilator Kit - Purple
In Commercial Distribution

  • 00819835023425 ()
BL-444111

  • Vaginal dilator

Wellness - 00819835024125

Wellness - Kegel Training Kit - Purple Part Number: BL-444004 Material: Silicone
Blush Novelties
Wellness - Kegel Training Kit - Purple
In Commercial Distribution

  • 00819835024125 ()
BL-444004

  • Perineometer

Elite Elastic Bandage - 00840155407633

Elite, Elastic Bandage, 6 / Elite First Aid Part Number: 503
MEDSOURCE INTERNATIONAL LLC
ELITE-EB006
In Commercial Distribution

  • 00840155407701 ()
  • 00840155407633 ()
  • 00840155407770 ()
Not Applicable

  • Non-adhesive device retention bandage

Elite Elastic Bandage - 00840155407626

Elite, Elastic Bandage 2 / Elite First Aid Part Number: 500
MEDSOURCE INTERNATIONAL LLC
ELITE-EB002
In Commercial Distribution

  • 00840155407626 ()
  • 00840155407695 ()
  • 00840155407763 ()
Not Applicable

  • Non-adhesive device retention bandage

VTI 8 MHZ Disposable Doppler Probe, Box - 10817122020468

Part Number 108280, VTI 8 MHZ Disposable Doppler Probe, Box
VASCULAR TECHNOLOGY, INCORPORATED
108280
In Commercial Distribution

  • 10817122020468 ()
  • 00817122020461 ()
108280

  • Invasive/noninvasive vascular ultrasound probe

Mizuho 07-150-12 20 MHz Micro Disposable Doppler Probe, Box - 10817122020338

Part Number 138665, 20 Mhz Micro Disposable Doppler Probe, Box
VASCULAR TECHNOLOGY, INCORPORATED
138665
In Commercial Distribution

  • 10817122020338 ()
  • 00817122020331 ()
138665

  • Invasive/noninvasive vascular ultrasound probe

Mizuho 07-150-21 20 MHz Disposable Doppler Probe Straight, Box - 10817122020284

Part Number 138220, 20 MHz Disposable Doppler Probe Straight, Box
VASCULAR TECHNOLOGY, INCORPORATED
138220
In Commercial Distribution

  • 10817122020284 ()
  • 00817122020287 ()
138220

  • Invasive/noninvasive vascular ultrasound probe

8 MHz Kelly Endonasal Disposable Doppler Probe, Box - 10817122020277

Part Number 138210, 8 MHz Kelly Endonasal Doppler Probe, Box
VASCULAR TECHNOLOGY, INCORPORATED
138210
In Commercial Distribution

  • 10817122020277 ()
  • 00817122020270 ()
138210

  • Invasive/noninvasive vascular ultrasound probe

Edwards FLO-003S Ultrasonic Blood Flow Detector Straight Probe, Box - 10817122020253

Part Number 128361, Ultrasonic Blood Flow Detector Straight Probe, Box
VASCULAR TECHNOLOGY, INCORPORATED
128361
Not in Commercial Distribution

  • 10817122020253 ()
  • 00817122020256 ()
128361

  • Invasive/noninvasive vascular ultrasound probe

Edwards FLO-002S Ultrasonic Blood Flow Detector Curved Probe, Box - 10817122020246

Part Number 128360, Ultrasonic Blood Flow Detector Curved Probe, Box
VASCULAR TECHNOLOGY, INCORPORATED
128360
Not in Commercial Distribution

  • 10817122020246 ()
  • 00817122020249 ()
128360

  • Invasive/noninvasive vascular ultrasound probe

VTI 20 MHz Disposable Doppler Probe, Box - 10817122020239

Part Number 108665, VTI 20 MHz Disposable Doppler Probe, Box
VASCULAR TECHNOLOGY, INCORPORATED
108665
In Commercial Distribution

  • 10817122020239 ()
  • 00817122020232 ()
108665

  • Invasive/noninvasive vascular ultrasound probe

Mizuho 07-150-22 20 MHz Disposable Doppler Probe Curved Tip, Box - 10817122020192

Part Number 138230 20 MHz Disposable Doppler Probe Curved, Box
VASCULAR TECHNOLOGY, INCORPORATED
138230
In Commercial Distribution

  • 10817122020192 ()
  • 00817122020195 ()
138230

  • Invasive/noninvasive vascular ultrasound probe

Remotely Operated Suction & Irrigation Tubing Set, Box - 10817122020031

Part Number 106410, Remotely Operated Suction Irrigation Tubing Set, Box
VASCULAR TECHNOLOGY, INCORPORATED
106410
In Commercial Distribution

  • 10817122020031 ()
  • 00817122020034 ()
106410

  • Surgical irrigation/aspiration tubing set

HAL for Medical Use - 04560340091084

Number of legs: Double Leg length: Long Hip width: Wide
CYBERDYNE, INC.
HAL-ML05-DLWUS
In Commercial Distribution

  • 04560340091084 ()


  • Neuro-controlled ambulation exoskeleton

HAL for Medical Use - 04560340091077

Number of legs: Double Leg length: Medium Hip width: Wide
CYBERDYNE, INC.
HAL-ML05-DMWUS
In Commercial Distribution

  • 04560340091077 ()


  • Neuro-controlled ambulation exoskeleton

HAL for Medical Use - 04560340090964

Number of legs: Double Leg length: Long Hip width: Medium
CYBERDYNE, INC.
HAL-ML05-DLMUS
In Commercial Distribution

  • 04560340090964 ()


  • Neuro-controlled ambulation exoskeleton

HAL for Medical Use - 04560340090957

Number of legs: Double Leg length: Medium Hip width: Medium
CYBERDYNE, INC.
HAL-ML05-DMMUS
In Commercial Distribution

  • 04560340090957 ()


  • Neuro-controlled ambulation exoskeleton
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