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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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Unimed - 06945664817677

SpO2 interface cable/北京麦邦/2.2M/048+170/Nellcor
Unimed Medical Supplies, Inc.
U708-92
In Commercial Distribution

  • 06945664817677 ()


  • Electrical-only medical device connection cable, reusable

Unimed - 06945664802536

Reusable SpO2 Sensor/北京麦邦/Finger clip/Adult/3.0M/048
Unimed Medical Supplies, Inc.
U410-92
In Commercial Distribution

  • 06945664802536 ()


  • Pulse oximeter probe, reusable

Unimed - 06945664821148

Reusable SpO2 Sensor/北京麦邦/Finger clip/Adult/1.5M/048
Unimed Medical Supplies, Inc.
U405-92
In Commercial Distribution

  • 06945664821148 ()


  • Pulse oximeter probe, reusable

中性 - 00697038425266

No Description
HONSUN (NANTONG) CO.,LTD
HS-70D
In Commercial Distribution

  • 00697038425266 ()


  • Aneroid manual sphygmomanometer

中性 - 00697038425259

No Description
HONSUN (NANTONG) CO.,LTD
HS-70A
In Commercial Distribution

  • 00697038425259 ()


  • Aneroid manual sphygmomanometer

中性 - 00697038425228

No Description
HONSUN (NANTONG) CO.,LTD
HS-20A
In Commercial Distribution

  • 00697038425228 ()


  • Aneroid manual sphygmomanometer

中性 - 00697038425198

No Description
HONSUN (NANTONG) CO.,LTD
HS-70B
In Commercial Distribution

  • 00697038425198 ()


  • Aneroid manual sphygmomanometer

中性 - 00697038425181

No Description
HONSUN (NANTONG) CO.,LTD
HS-60A
In Commercial Distribution

  • 00697038425181 ()


  • Aneroid manual sphygmomanometer

中性 - 00697038425167

No Description
HONSUN (NANTONG) CO.,LTD
HS-201K1
In Commercial Distribution

  • 00697038425167 ()


  • Aneroid manual sphygmomanometer

中性 - 00697038425143

No Description
HONSUN (NANTONG) CO.,LTD
HS-20
In Commercial Distribution

  • 00697038425143 ()


  • Aneroid manual sphygmomanometer

中性 - 10697038425263

No Description
HONSUN (NANTONG) CO.,LTD
HS-70D
In Commercial Distribution

  • 10697038425263 ()


  • Aneroid manual sphygmomanometer

中性 - 10697038425256

No Description
HONSUN (NANTONG) CO.,LTD
HS-70A
In Commercial Distribution

  • 10697038425256 ()


  • Aneroid manual sphygmomanometer

中性 - 10697038425225

No Description
HONSUN (NANTONG) CO.,LTD
HS-20A
In Commercial Distribution

  • 10697038425225 ()
  • 00697038425228 ()


  • Aneroid manual sphygmomanometer

中性 - 10697038425188

No Description
HONSUN (NANTONG) CO.,LTD
HS-60A
In Commercial Distribution

  • 10697038425188 ()
  • 00697038425181 ()


  • Aneroid manual sphygmomanometer

中性 - 10697038425164

No Description
HONSUN (NANTONG) CO.,LTD
HS-201K1
In Commercial Distribution

  • 10697038425164 ()
  • 00697038425167 ()


  • Aneroid manual sphygmomanometer

中性 - 10697038425140

No Description
HONSUN (NANTONG) CO.,LTD
HS-20A
In Commercial Distribution

  • 10697038425140 ()
  • 00697038425143 ()


  • Aneroid manual sphygmomanometer

Unimed - 06945664824972

SpO2 interface cable/安维生-Philips/3.0M/087
Unimed Medical Supplies, Inc.
U710-169
In Commercial Distribution

  • 06945664824972 ()


  • Electrical-only medical device connection cable, reusable

Unimed - 06945664824958

SpO2 interface cable/安维生-Nellcor/3.0M/103X
Unimed Medical Supplies, Inc.
U710-170
In Commercial Distribution

  • 06945664824958 ()


  • Electrical-only medical device connection cable, reusable

Unimed - 06945664817660

SpO2 interface cable/安维生/3.0M/073/客户订做
Unimed Medical Supplies, Inc.
U710-172
In Commercial Distribution

  • 06945664817660 ()


  • Electrical-only medical device connection cable, reusable

Unimed - 06945664821131

Reusable SpO2 Sensor/奥生科技/Finger clip/Adult/3.0M/LP6-40B
Unimed Medical Supplies, Inc.
U410-159D
In Commercial Distribution

  • 06945664821131 ()


  • Pulse oximeter probe, reusable

Unimed - 06945664856577

Reusable Thermometer Probe/20K/Adult/Skin/LP2单公/1.6M/郑州迪生
Unimed Medical Supplies, Inc.
TDS-16AS
In Commercial Distribution

  • 06945664856577 ()


  • General-purpose patient temperature probe, reusable

MANI Sutures Nylon - 04546951500061

No Description
MANI, INC.
15
In Commercial Distribution

  • 04546951500061 ()
  • 14546951500068 ()
15

  • Nylon suture, non-bioabsorbable, monofilament

M-Brace Air - 05391512280123

The Mercurio Ankle Lock brace, with elastic, reinforced strap to be applied to the ankle using our locking system. In order to ensure maximum comfort and tolerance, especially in the case of extended use, particular care and attention have been dedicated to the selection of materials and fabrics. As such, our products are made exclusively with all natural, hypo-allergenic and breathable fibers. The inside fabric of this product is the result of a unique technology. It is made with very soft cotton velour providing the skin with an extremely comfortable touch and at the same time, allowing it to breathe freely all day-even while playing sports.
INDACO SRL
15 R
In Commercial Distribution

  • 05391512285043 ()
  • 05391512280123 ()
15

  • Ankle binder, reusable

Royal Pink Polymer - D85115

Tinted Powder
JBC and Company
15
In Commercial Distribution

  • D85115 ()
15

  • Dental appliance fabrication material, resin

Dentivera Milling Disc - 00850287007007

Dentivera 18mm Disc, White A1 Shade
SOLVAY SPECIALTY POLYMERS USA, L.L.C.
A001
In Commercial Distribution

  • 00850287007007 ()
15

  • Dental appliance fabrication material, thermoplastic

3M™ ESPE™ - 30605861024878

3M™ ESPE™ Adult Anterior Polycarbonate Replacement Crown, Upper Left Centrals, Size 15, 15
3M COMPANY
15
In Commercial Distribution

  • 50605861024872 ()
  • 30605861024878 ()
  • 00605861021951 ()
15

  • Preformed dental crown, temporary

P 1-5 - 08056304452931

No Description
ESAOTE SPA
120000015
In Commercial Distribution

  • 08056304452931 ()


  • Extracorporeal ultrasound imaging transducer, hand-held

PX 1-5 - 08056304454287

No Description
ESAOTE SPA
120000066
In Commercial Distribution

  • 08056304454287 ()


  • Extracorporeal ultrasound imaging transducer, hand-held

HLA-C*15 - 07340035506300

No Description
CareDx AB
101.626-12u
In Commercial Distribution

  • 07340035506300 ()


  • HLA class I antigen tissue typing IVD, kit, multiplex

ELEVATOR #15 - D9281040150

No Description
W.H. Holden, Inc.
10-4015
In Commercial Distribution

  • D9281040150 ()


  • Dental elevator, tooth/root

SEMIAL 15° - 04047844002186

The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame with tapered edges. The frame is made from PEEK-OPTIMA®. SEMIAL® spinal implants have a semi-cylindrical form and are hollow. The implant is made from PEEK-OPTIMA®. The provision of varying heights, together with a wedge shaped option, allow better lordosis control. The TETRIS® implants (PEEK and Titanium) are hollow having a rectangular frame with lateral fenestrations. The upper and lower aspects of the implant are open and the walls feature spikes which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies. These implants are available in a variety of dimensional and angular sizes. This enables the surgeon to choose the size suited to the individual pathology and anatomy and condition. The MOBIS, NOVAL, SEMIAL and PEEK TETRIS devices are manufactured from polyetheretherketone (PEEK-OPTIMA® LT1, Invibio™) as described by ASTM F2026. Integral marker pins are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3 or tantalum as described by ASTM F560. The Titanium TETRIS devices are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3. The KIMBA® and KIMBA® mini devices are manufactured from ECF PEEK OPTIMA (Invibio™).
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844002186 ()

  • 16x43mm
SK151643

  • Polymeric spinal interbody fusion cage

SEMIAL 15° - 04047844002179

The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame with tapered edges. The frame is made from PEEK-OPTIMA®. SEMIAL® spinal implants have a semi-cylindrical form and are hollow. The implant is made from PEEK-OPTIMA®. The provision of varying heights, together with a wedge shaped option, allow better lordosis control. The TETRIS® implants (PEEK and Titanium) are hollow having a rectangular frame with lateral fenestrations. The upper and lower aspects of the implant are open and the walls feature spikes which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies. These implants are available in a variety of dimensional and angular sizes. This enables the surgeon to choose the size suited to the individual pathology and anatomy and condition. The MOBIS, NOVAL, SEMIAL and PEEK TETRIS devices are manufactured from polyetheretherketone (PEEK-OPTIMA® LT1, Invibio™) as described by ASTM F2026. Integral marker pins are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3 or tantalum as described by ASTM F560. The Titanium TETRIS devices are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3. The KIMBA® and KIMBA® mini devices are manufactured from ECF PEEK OPTIMA (Invibio™).
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844002179 ()

  • 14x43mm
SK151443

  • Polymeric spinal interbody fusion cage

VERTACONNECT 15° - 04047844066737

The VERTACONNECT TLIF Spreadable Lumbar Cage is a spacer for implantation in aprepared intervertebral disc space of the lumbar spine. Its design offers stable contact surfaces, toothed implant/bone surfaces and large cage windows. The open implant design supports a bony construction of the intervertebral disc space. The implants consist of a cage and a pre-assembled expansion element.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844066737 ()

  • 37x19/10mm
CAT371910

  • Metallic spinal interbody fusion cage

VERTACONNECT 15° - 04047844066713

The VERTACONNECT TLIF Spreadable Lumbar Cage is a spacer for implantation in aprepared intervertebral disc space of the lumbar spine. Its design offers stable contact surfaces, toothed implant/bone surfaces and large cage windows. The open implant design supports a bony construction of the intervertebral disc space. The implants consist of a cage and a pre-assembled expansion element.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844066713 ()

  • 37x17/8mm
CAT371708

  • Metallic spinal interbody fusion cage

VERTACONNECT 15° - 04047844066683

The VERTACONNECT TLIF Spreadable Lumbar Cage is a spacer for implantation in aprepared intervertebral disc space of the lumbar spine. Its design offers stable contact surfaces, toothed implant/bone surfaces and large cage windows. The open implant design supports a bony construction of the intervertebral disc space. The implants consist of a cage and a pre-assembled expansion element.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844066683 ()

  • 34x18/10mm
CAT341810

  • Metallic spinal interbody fusion cage

VERTACONNECT 15° - 04047844066669

The VERTACONNECT TLIF Spreadable Lumbar Cage is a spacer for implantation in aprepared intervertebral disc space of the lumbar spine. Its design offers stable contact surfaces, toothed implant/bone surfaces and large cage windows. The open implant design supports a bony construction of the intervertebral disc space. The implants consist of a cage and a pre-assembled expansion element.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844066669 ()

  • 34x16/8mm
CAT341608

  • Metallic spinal interbody fusion cage

VERTACONNECT 15° - 04047844066638

The VERTACONNECT TLIF Spreadable Lumbar Cage is a spacer for implantation in aprepared intervertebral disc space of the lumbar spine. Its design offers stable contact surfaces, toothed implant/bone surfaces and large cage windows. The open implant design supports a bony construction of the intervertebral disc space. The implants consist of a cage and a pre-assembled expansion element.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844066638 ()

  • 31x17/10mm
CAT311710

  • Metallic spinal interbody fusion cage

VERTACONNECT 15° - 04047844066614

The VERTACONNECT TLIF Spreadable Lumbar Cage is a spacer for implantation in aprepared intervertebral disc space of the lumbar spine. Its design offers stable contact surfaces, toothed implant/bone surfaces and large cage windows. The open implant design supports a bony construction of the intervertebral disc space. The implants consist of a cage and a pre-assembled expansion element.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844066614 ()

  • 31x15/8mm
CAT311508

  • Metallic spinal interbody fusion cage

MEGAPULSE 15+ - 04055207054024

LASER FIBER Ø 600µM DISPOSABLE Core Diameter 600µm, PACK=5 PCS, sterile, for single use
Richard Wolf GmbH
487501605
Not in Commercial Distribution

  • 04055207054024 ()
  • 04055207054031 ()

  • Outer Diameter: 600 Micrometer
487501605

  • Laser lithotripsy system

MEGAPULSE 15+ - 04055207054000

LASER FIBER Ø 365µM DISPOSABLE Core Diameter 365µm, PACK=5 PCS, sterile, for single use
Richard Wolf GmbH
487501365
Not in Commercial Distribution

  • 04055207054000 ()
  • 04055207054017 ()

  • Outer Diameter: 365 Micrometer
487501365

  • Laser lithotripsy system

MEGAPULSE 15+ - 04055207053980

LASER FIBER Ø 230µM DISPOSABLE Core Diameter 230µm, PACK=5 PCS, sterile, for single use
Richard Wolf GmbH
487501235
Not in Commercial Distribution

  • 04055207053980 ()
  • 04055207053997 ()

  • Outer Diameter: 230 Micrometer
487501235

  • Laser lithotripsy system

DIALFIX 15 - 08800125000037

No Description
DFIX
01
In Commercial Distribution

  • 08800125000037 ()

  • Wound size 15 to 20cm


  • Skin-closing tension device

StoneLight 15 - 00859932006013

Ho:YAG Laser System
NEW STAR LASERS, INC.
7300-0028
Not in Commercial Distribution

  • 00859932006013 ()
NS1800

  • General/multiple surgical solid-state laser system

CORVUS 15 - 00852656007502

CORVUS 15 is intended for use as a planning tool for conformal radiation therapy. The CORVUS system is intended to be used as an integrated system with a delivery device for planning and delivery of conformal radiation therapy. . For IMRT, using operator-supplied input and patient scans, it creates a plan for treatment delivery systems and generates a set of beam weights that, when applied to a compatible system, facilitates delivery of an intensity-modulated 3D conformal radiation therapy treatment. For Forward Planning, CORVUS helps the user manually create a plan for treatment delivery based on user supplied inputs and patient scans including dose calculation. Forward Planning is supported only for Cobalt-60 based treatment planning.
Best Nomos
210764
In Commercial Distribution

  • 00852656007502 ()


  • Radiation therapy software

Access 15 - 03596010441546

PUMP CART ACCESS 15 PUMP
Smith & Nephew, Inc.
7205932
In Commercial Distribution

  • 03596010441546 ()
7205932

  • Instrument trolley

ACCESS 15 - 03596010441522

REMOTE CONTROL ACCESS 15 PUMP
Smith & Nephew, Inc.
7205797
In Commercial Distribution

  • 03596010441522 ()
7205797

  • Endoscopic device remote control

SAROS 15 - M766AS00710

Portable Oxygen Concentrator 0.5-15 LPM, Continuous and Pulse Dose Settings
CAIRE INC.
AS007-1
In Commercial Distribution

  • M766AS00710 ()


  • Mobile/portable oxygen concentrator

15 CompreSleeve - 00745129302436

Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the affected limb by providing consistent, firm pressure. Can be used throughout the phases of decongestive therapy to reduce swelling and shape the limb. Available with or without a prescription. Its important to note that specific therapy or approaches used for lymphedema management should be tailored by the healthcare provider. This is a reusable, washable device.
SIGVARIS INC
15BK
In Commercial Distribution

  • 00745129302436 ()

  • Pressure,15-20 mmHg
1505-BKT-BC

  • General-purpose medical foam padding, single-use
  • General-purpose medical fibre padding

15 CompreSleeve - 00745129302429

Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the affected limb by providing consistent, firm pressure. Can be used throughout the phases of decongestive therapy to reduce swelling and shape the limb. Available with or without a prescription. Its important to note that specific therapy or approaches used for lymphedema management should be tailored by the healthcare provider. This is a reusable, washable device.
SIGVARIS INC
15BK
In Commercial Distribution

  • 00745129302429 ()

  • Pressure,15-20 mmHg
1505-BKS-BC

  • General-purpose medical foam padding, single-use
  • General-purpose medical fibre padding

15 CompreSleeve - 00745129302412

Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the affected limb by providing consistent, firm pressure. Can be used throughout the phases of decongestive therapy to reduce swelling and shape the limb. Available with or without a prescription. Its important to note that specific therapy or approaches used for lymphedema management should be tailored by the healthcare provider. This is a reusable, washable device.
SIGVARIS INC
15BK
In Commercial Distribution

  • 00745129302412 ()

  • Pressure,15-20 mmHg
1505-BKR-BC

  • General-purpose medical foam padding, single-use
  • General-purpose medical fibre padding
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