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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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Lightning X Products,Inc - 06974567745442

No Description
Wuxi Emsrun Technology Co., Ltd.
LXEB2
In Commercial Distribution

  • 06974567745442 ()


  • First aid absorbent pad/bandage

Lightning X Products,Inc - 06974567745435

No Description
Wuxi Emsrun Technology Co., Ltd.
LXTSB
In Commercial Distribution

  • 06974567745435 ()


  • Bandage scissors, reusable

Lightning X Products,Inc - 06974567745428

No Description
Wuxi Emsrun Technology Co., Ltd.
LXEFB
In Commercial Distribution

  • 06974567745428 ()


  • Rescue blanket, reusable

NovaPlug 2cm x 1cm - 00813909011462

Collagen wound dressing
NOVABONE PRODUCTS, LLC
NA2200
In Commercial Distribution

  • 00813909011462 ()
  • 00813909010465 ()

  • Outer Diameter: 1 Centimeter
  • Length: 2 Centimeter
NA2200

  • General oral wound dressing, animal-derived

3.9mm x 50mm HCS - 00850015496660

3.9mm x 50mm Headless Compression Screw
Osteocentric Technologies, Inc.
801-23950
In Commercial Distribution

  • 00850015496660 ()

  • Length: 50 Millimeter
  • Outer Diameter: 3.9 Millimeter
801-23950

  • Orthopaedic bone screw (non-sliding)

3.9mm x 45mm HCS - 00850015496653

3.9mm x 45mm Headless Compression Screw
Osteocentric Technologies, Inc.
801-23945
In Commercial Distribution

  • 00850015496653 ()

  • Length: 45 Millimeter
  • Outer Diameter: 3.9 Millimeter
801-23945

  • Orthopaedic bone screw (non-sliding)

3.9mm x 40mm HCS - 00850015496646

3.9mm x 40mm Headless Compression Screw
Osteocentric Technologies, Inc.
801-23940
In Commercial Distribution

  • 00850015496646 ()

  • Length: 40 Millimeter
  • Outer Diameter: 3.9 Millimeter
801-23940

  • Orthopaedic bone screw (non-sliding)

3.9mm x 34mm HCS - 00850015496639

3.9mm x 34mm Headless Compression Screw
Osteocentric Technologies, Inc.
801-23934
In Commercial Distribution

  • 00850015496639 ()

  • Length: 34 Millimeter
  • Outer Diameter: 3.9 Millimeter
801-23934

  • Orthopaedic bone screw (non-sliding)

3.9mm x 32mm HCS - 00850015496622

3.9mm x 32mm Headless Compression Screw
Osteocentric Technologies, Inc.
801-23932
In Commercial Distribution

  • 00850015496622 ()

  • Length: 32 Millimeter
  • Outer Diameter: 3.9 Millimeter
801-23932

  • Orthopaedic bone screw (non-sliding)

3.9mm x 30mm HCS - 00850015496615

3.9mm x 30mm Headless Compression Screw
Osteocentric Technologies, Inc.
801-23930
In Commercial Distribution

  • 00850015496615 ()

  • Length: 30 Millimeter
  • Outer Diameter: 3.9 Millimeter
801-23930

  • Orthopaedic bone screw (non-sliding)

3.9mm x 28mm HCS - 00850015496608

3.9mm x 28mm Headless Compression Screw
Osteocentric Technologies, Inc.
801-23928
In Commercial Distribution

  • 00850015496608 ()

  • Length: 28 Millimeter
  • Outer Diameter: 3.9 Millimeter
801-23928

  • Orthopaedic bone screw (non-sliding)

3.9mm x 26mm HCS - 00850015496592

3.9mm x 26mm Headless Compression Screw
Osteocentric Technologies, Inc.
801-23926
In Commercial Distribution

  • 00850015496592 ()

  • Length: 26 Millimeter
  • Outer Diameter: 3.9 Millimeter
801-23926

  • Orthopaedic bone screw (non-sliding)

3.9mm x 24mm HCS - 00850015496585

3.9mm x 24mm Headless Compression Screw
Osteocentric Technologies, Inc.
801-23924
In Commercial Distribution

  • 00850015496585 ()

  • Length: 24 Millimeter
  • Outer Diameter: 3.9 Millimeter
801-23924

  • Orthopaedic bone screw (non-sliding)

3.9mm x 22mm HCS - 00850015496578

3.9mm x 22mm Headless Compression Screw
Osteocentric Technologies, Inc.
801-23922
In Commercial Distribution

  • 00850015496578 ()

  • Length: 22 Millimeter
  • Outer Diameter: 3.9 Millimeter
801-23922

  • Orthopaedic bone screw (non-sliding)

3.9mm x 20mm HCS - 00850015496561

3.9mm x 20mm Headless Compression Screw
Osteocentric Technologies, Inc.
801-23920
In Commercial Distribution

  • 00850015496561 ()

  • Length: 20 Millimeter
  • Outer Diameter: 3.9 Millimeter
801-23920

  • Orthopaedic bone screw (non-sliding)

3.9mm x 18mm HCS - 00850015496554

3.9mm x 18mm Headless Compression Screw
Osteocentric Technologies, Inc.
801-23918
In Commercial Distribution

  • 00850015496554 ()

  • Length: 18 Millimeter
  • Outer Diameter: 3.9 Millimeter
801-23918

  • Orthopaedic bone screw (non-sliding)

3.9mm x 16mm HCS - 00850015496547

3.9mm x 16mm Headless Compression Screw
Osteocentric Technologies, Inc.
801-23916
In Commercial Distribution

  • 00850015496547 ()

  • Length: 16 Millimeter
  • Outer Diameter: 3.9 Millimeter
801-23916

  • Orthopaedic bone screw (non-sliding)

2.8mm x 30mm HCS - 00850015496530

2.8mm x 30mm Headless Compression Screw
Osteocentric Technologies, Inc.
801-22830
In Commercial Distribution

  • 00850015496530 ()

  • Length: 30 Millimeter
  • Outer Diameter: 2.8 Millimeter
801-22830

  • Orthopaedic bone screw (non-sliding)

2.8mm x 28mm HCS - 00850015496523

2.8mm x 28mm Headless Compression Screw
Osteocentric Technologies, Inc.
801-22828
In Commercial Distribution

  • 00850015496523 ()

  • Length: 28 Millimeter
  • Outer Diameter: 2.8 Millimeter
801-22828

  • Orthopaedic bone screw (non-sliding)

2.8mm x 26mm HCS - 00850015496516

2.8mm x 26mm Headless Compression Screw
Osteocentric Technologies, Inc.
801-22826
In Commercial Distribution

  • 00850015496516 ()

  • Length: 26 Millimeter
  • Outer Diameter: 2.8 Millimeter
801-22826

  • Orthopaedic bone screw (non-sliding)

2.8mm x 24mm HCS - 00850015496509

2.8mm x 24mm Headless Compression Screw
Osteocentric Technologies, Inc.
801-22824
In Commercial Distribution

  • 00850015496509 ()

  • Length: 24 Millimeter
  • Outer Diameter: 2.8 Millimeter
801-22824

  • Orthopaedic bone screw (non-sliding)

2.8mm x 22mm HCS - 00850015496493

2.8mm x 22mm Headless Compression Screw
Osteocentric Technologies, Inc.
801-22822
In Commercial Distribution

  • 00850015496493 ()

  • Length: 22 Millimeter
  • Outer Diameter: 2.8 Millimeter
801-22822

  • Orthopaedic bone screw (non-sliding)

2.8mm x 20mm HCS - 00850015496486

2.8mm x 20mm Headless Compression Screw
Osteocentric Technologies, Inc.
801-22820
In Commercial Distribution

  • 00850015496486 ()

  • Length: 20 Millimeter
  • Outer Diameter: 2.8 Millimeter
801-22820

  • Orthopaedic bone screw (non-sliding)

2.8mm x 18mm HCS - 00850015496479

2.8mm x 18mm Headless Compression Screw
Osteocentric Technologies, Inc.
801-22818
In Commercial Distribution

  • 00850015496479 ()

  • Length: 18 Millimeter
  • Outer Diameter: 2.8 Millimeter
801-22818

  • Orthopaedic bone screw (non-sliding)

2.8mm x 16mm HCS - 00850015496462

2.8mm x 16mm Headless Compression Screw
Osteocentric Technologies, Inc.
801-22816
In Commercial Distribution

  • 00850015496462 ()

  • Length: 16 Millimeter
  • Outer Diameter: 2.8 Millimeter
801-22816

  • Orthopaedic bone screw (non-sliding)

2.8mm x 14mm HCS - 00850015496455

2.8mm x 14mm Headless Compression Screw
Osteocentric Technologies, Inc.
801-22814
In Commercial Distribution

  • 00850015496455 ()

  • Length: 14 Millimeter
  • Outer Diameter: 2.8 Millimeter
801-22814

  • Orthopaedic bone screw (non-sliding)

2.8mm x 12mm HCS - 00850015496448

2.8mm x 12mm Headless Compression Screw
Osteocentric Technologies, Inc.
801-22812
In Commercial Distribution

  • 00850015496448 ()

  • Length: 12 Millimeter
  • Outer Diameter: 2.8 Millimeter
801-22812

  • Orthopaedic bone screw (non-sliding)

Astroglide X Silicone Liquid - 00015594000046

Astroglide® X Silicone Personal Lubricant is a personal lubricant for penile, vaginal, and/or anal application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyisoprene and polyurethane condoms.
BIOFILM, INC
015594000046
In Commercial Distribution

  • 00015594000046 ()

  • Total Volume: 12 Fluid Ounce
N/A

  • Sexual lubricant

SPLENDOR X ALEX + Nd:YAG - 08052049500067

No Description
BIOS SRL
APMD122.SPX
In Commercial Distribution

  • 08052049500067 ()


  • Dermatological solid-state laser system

Mazor X Navigation Camera - 07290109183602

No Description
MAZOR ROBOTICS LTD
TPL0063-02
Not in Commercial Distribution

  • 07290109183602 ()


  • Multi-purpose stereotactic surgery system

Mazor X Surgical Instruments - 07290109183275

No Description
MAZOR ROBOTICS LTD
KIT0552-05
Not in Commercial Distribution

  • 07290109183275 ()


  • Stereotactic surgery system probe, reusable

Mazor X Navigation Camera - 07290109181912

No Description
MAZOR ROBOTICS LTD
TPL0063-01
Not in Commercial Distribution

  • 07290109181912 ()


  • Multi-purpose stereotactic surgery system

Mazor X Surgical Instruments - 07290109181165

No Description
MAZOR ROBOTICS LTD
KIT0552-04
Not in Commercial Distribution

  • 07290109181165 ()


  • Stereotactic surgery system probe, reusable

Mazor X Surgical Instruments - 07290109181028

Mazor X Surgical Instruments
MAZOR ROBOTICS LTD
KIT0552-03
Not in Commercial Distribution

  • 07290109181028 ()


  • Stereotactic surgery system probe, reusable

Mazor X Surgical Instruments - 07290109180090

Mazor X Surgical Instruments
MAZOR ROBOTICS LTD
KIT0552-02
Not in Commercial Distribution

  • 07290109180090 ()
KIT0552-02

  • Stereotactic surgery system probe, reusable

Lightning X Products,Inc - 06974567745657

No Description
Wuxi Emsrun Technology Co., Ltd.
LX-Tape Duct
In Commercial Distribution

  • 06974567745657 ()


  • Multi-purpose surgical skin adhesive tape

26MM X 3CM X 55CM ASCENDRA 3 DELIVERY SYSTEM - 00690103191936

No Description
Edwards Lifesciences LLC
9120AS26A
In Commercial Distribution

  • 00690103191936 ()

  • 26 MILIMETER DIAMETER NOMINAL BALLOON DIAMETER
9120AS26A

  • Cardiac valvuloplasty catheter

23MM X 3CM X 55CM ASCENDRA 3 DELIVERY SYSTEM - 00690103191929

No Description
Edwards Lifesciences LLC
9120AS23A
In Commercial Distribution

  • 00690103191929 ()

  • 23 MILIMETER DIAMETER NOMINAL BALLOON DIAMETER
9120AS23A

  • Cardiac valvuloplasty catheter

26 MM X 3CM X 110CM RETROFLEX DELIVERY SYSTEM - 00690103181999

No Description
Edwards Lifesciences LLC
9120FS26
In Commercial Distribution

  • 00690103181999 ()

  • 26 MILIMETER DIAMETER NOMINAL BALLOON DIAMETER
9120FS26

  • Catheter introducer

23 MM X 3CM X 110CM RETROFLEX DELIVERY SYSTEM - 00690103181982

No Description
Edwards Lifesciences LLC
9120FS23
In Commercial Distribution

  • 00690103181982 ()

  • 23 MILIMETER DIAMETER NOMINAL BALLOON DIAMETER
9120FS23

  • Catheter introducer

FLEXITIME MEDIUM FLOW 6 X (2 X 50 ML) - J014660410620

Material, Impression
Kulzer GmbH
66041062
Not in Commercial Distribution

  • J014660410620 ()
66041062

  • Polyether dental impression material

FLEXITIME LIGHT FLOW 6 X (2 X 50 ML) - J014660410610

Material, Impression
Kulzer GmbH
66041061
Not in Commercial Distribution

  • J014660410610 ()
66041061

  • Polyether dental impression material

GAS SAMPLING LINE 96'x.050'x.112' MM - 00859290006311

Truer Medical Gas Sampling Lines are manufactured to the highest quality standards using medical-grade materials. Standard luer connection ensures secure fit
TRUER MEDICAL, INC.
90156
In Commercial Distribution

  • 10859290006318 ()
  • 00859290006311 ()
  • 20859290006315 ()
  • 30859290006312 ()
90156

  • Gas-sampling/monitoring respiratory tubing, single-use

PosiSep X 0.6 x 2.0 Hemostatic Dressing/Intranasal Splint - 00858439001330

PosiSep X devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep X devices expand when hydrated providing separation between the sinus tissues.
HEMOSTASIS, LLC
9210584
In Commercial Distribution

  • 00858439001354 ()
  • 00858439001330 ()
  • 00858439001347 ()

  • Width: 1.5 Centimeter
  • Length: 5.1 Centimeter


  • Chitosan haemostatic agent, professional, non-bioabsorbable
  • Intranasal splint, non-bioabsorbable, animal-derived

PosiSep X 0.5 x 1.5 Hemostatic Dressing/Intranasal Splint - 00858439001279

PosiSep X devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep X devices expand when hydrated providing separation between the sinus tissues.
HEMOSTASIS, LLC
9210564
In Commercial Distribution

  • 00858439001286 ()
  • 00858439001279 ()

  • Width: 1.3 Centimeter
  • Length: 3.8 Centimeter


  • Chitosan haemostatic agent, professional, non-bioabsorbable
  • Intranasal splint, non-bioabsorbable, animal-derived

Bolus Material 60 x 40 x 0,5 with film - 09120074396616

No Description
IT-V Medizintechnik GmbH
P10107-661
Not in Commercial Distribution

  • 09120074396616 ()


  • Radiological whole-body positioner

Bolus Material 60 x 40 x 0,3 with film - 09120074396609

No Description
IT-V Medizintechnik GmbH
P10107-660
Not in Commercial Distribution

  • 09120074396609 ()


  • Radiological whole-body positioner

Bolus Material 40 x 40 x 1,0 with film - 09120074396593

No Description
IT-V Medizintechnik GmbH
P10107-659
Not in Commercial Distribution

  • 09120074396593 ()


  • Radiological whole-body positioner

Bolus Material 40 x 40 x 0,5 with film - 09120074396586

No Description
IT-V Medizintechnik GmbH
P10107-658
Not in Commercial Distribution

  • 09120074396586 ()


  • Radiological whole-body positioner

Bolus Material 30 x 30 x 1,5 no film - 09120074396456

No Description
IT-V Medizintechnik GmbH
P10107-645
Not in Commercial Distribution

  • 09120074396456 ()


  • Radiological whole-body positioner
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