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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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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

HAL for Medical Use - 04560340090940

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

  • 04560340090940 ()


  • Neuro-controlled ambulation exoskeleton

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

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

Surgical Direct - B382SD1105000200

5mm 45cm Bipolar Rippled Bar Insert for item number SD110510000
Surgical Direct, Inc.
SD110500020
In Commercial Distribution

  • B382SD1105000200 ()
SD110500020

  • Endoscopic electrosurgical handpiece/electrode, bipolar, reusable

Surgical Direct - B382SD1105000100

5mm 33cm Bipolar Rippled Bar Insert for item number SD110510000
Surgical Direct, Inc.
SD110500010
In Commercial Distribution

  • B382SD1105000100 ()
SD110500010

  • Endoscopic electrosurgical handpiece/electrode, bipolar, reusable

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 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

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

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 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

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

OEM CUSTOMER SPECIFIC - 50192253051122

Insert Cups, 16 mm, Beckman Coulter, Inc. Part Number 81917
Cardinal Health 200, LLC
1270103585
In Commercial Distribution

  • 10192253051124 ()
  • 50192253051122 ()

  • Height: 16 Millimeter
1270103585

  • Blood collection tube holder, single-use

Delice - 00810138370834

Delice - Chéri - Kegel Trainer - Purple Part Number: BL-23721 Material: Silicone
Blush Novelties
Delice - Chéri - Kegel Trainer - Purple
In Commercial Distribution

  • 00810138370834 ()
BL-23721

  • Perineometer

Simplex - 07613327128444

Full Dose Bone Cement, 10 pack catalog number is 6191-1-010
Howmedica Osteonics Corp.
6191-1-001
In Commercial Distribution

  • 37613327128445 ()
  • 07613327128444 ()
  • 57613327128449 ()

  • Weight: 40.0 Gram
  • Total Volume: 20.0 Milliliter
6191-1-001

  • Orthopaedic cement, non-antimicrobial

Simplex - 07613327128437

Half Dose Bone Cement, 10 pack catalog number is 6188-1-010
Howmedica Osteonics Corp.
6188-1-001
In Commercial Distribution

  • 57613327128432 ()
  • 37613327128438 ()
  • 07613327128437 ()

  • Total Volume: 10.0 Milliliter
  • Weight: 20.0 Gram
6188-1-001

  • Orthopaedic cement, non-antimicrobial

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

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

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

K-2oem ALT-AIRE+ - 00817012022353

On-Demand Low Air loss Expandable mattress system, 80"-84"-88" x 36"-42"-48" x 10"
KAP MEDICAL
U-K-2oemXMS
In Commercial Distribution

  • 00817012022353 ()
U-K-2oemXMS

  • Low-air-loss bed

K-6 TURN-ZONE - 00817012022308

Alternating Pressure Lateral Rotation Expandable Mattress System, 80"-84"-88" x 36"-42"-48" x 10"
KAP MEDICAL
U-K-6XMS
In Commercial Distribution

  • 00817012022308 ()
U-K-6XMS

  • Low-air-loss bed

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

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

HUDSON RCI - 14026704656339

Color-Coded Guedel Airway 90 mm
TELEFLEX INCORPORATED
IPN029560
In Commercial Distribution

  • 34026704656333 ()
  • 14026704656339 ()
1159

  • Oropharyngeal airway, single-use

Inion CompressOn™ Screw - 06438408008832

6.0 x 90 mm screw
Inion Oy
1
In Commercial Distribution

  • 06438408008832 ()
OSH-6090

  • Bioabsorbable orthopaedic bone screw

Inion FreedomScrew™ - 06438408003363

Screw 4.5 x 90 mm
Inion Oy
1
In Commercial Distribution

  • 06438408003363 ()
OSA-4590

  • Bioabsorbable orthopaedic bone screw
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