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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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HPS Trocar cannulated with K-wire - 04260148896637

No Description
Paradigm Spine GmbH
HAT5010K
In Commercial Distribution

  • 04260148896637 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

HPS Cannulated Handle with Ratchet - 04260148896521

No Description
Paradigm Spine GmbH
HAT40122
In Commercial Distribution

  • 04260148896521 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

HPS Awl with blunt tip - 04260148896248

No Description
Paradigm Spine GmbH
HAT50250
In Commercial Distribution

  • 04260148896248 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

HPS Cannulated Handle with Ratchet - 04260148896187

No Description
Paradigm Spine GmbH
HAT40120
In Commercial Distribution

  • 04260148896187 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

DSS™ Trocar with spacer - 04260148893339

No Description
Paradigm Spine GmbH
DAT50101
In Commercial Distribution

  • 04260148893339 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

DSS, Measuring adapter with k-wire - 04260148893117

No Description
Paradigm Spine GmbH
DAT30425
In Commercial Distribution

  • 04260148893117 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SKORE Thin Condoms with Flavors - 08906007135511

The SKORE Thin Condoms with flavors - SKORE SKINTHIN condom is made of natural rubber latex. It is straight walled, smooth, teat ended, transparent, silicone oil with Zeus odor masker male condoms. It meets the requirements as specified in ISO 4074:2015 – Natural rubber latex male condoms – Requirements and test methods and ASTM D3492:2016– Standard Specification for Rubber Contraceptives (Male Condoms). The SKORE Thin Condoms with flavors - SKORE SKINTHIN natural rubber latex condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
TTK HEALTHCARE LIMITED
SKORE SKINTHIN
In Commercial Distribution

  • 08906007135528 ()
  • 08906007135511 ()
  • 08906007135535 ()
  • 08906007135542 ()


  • Basic male condom, Hevea-latex

SKORE Thin Condoms with Flavors - 08906007135474

The SKORE Thin Condoms with Flavors - SKORE NOTHING Chocolate condom is made of natural rubber latex. It is straight walled, smooth, teat ended, transparent, Chocolate flavored male condoms. It meets the requirements as specified in ISO 4074:2015 – Natural rubber latex male condoms – Requirements and test methods and ASTM D3492:2016– Standard Specification for Rubber Contraceptives (Male Condoms). The SKORE Thin Condoms with flavors - SKORE NOTHING Chocolate natural rubber latex condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
TTK HEALTHCARE LIMITED
SKORE NOTHING Chocolate
In Commercial Distribution

  • 08906007135481 ()
  • 08906007135474 ()
  • 08906007135498 ()
  • 08906007135504 ()


  • Basic male condom, Hevea-latex

SKORE Thin Condoms with Flavors - 08906007135436

The SKORE Thin Condoms with flavors - SKORE NOTHING Strawberry condom is made of natural rubber latex. It is straight walled, smooth, teat ended, transparent strawberry flavored male condoms. It meets the requirements as specified in ISO 4074:2015 – Natural rubber latex male condoms – Requirements and test methods and ASTM D3492:2016– Standard Specification for Rubber Contraceptives (Male Condoms). The SKORE Thin Condoms with flavors- SKORE NOTHING Strawberry natural rubber latex condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
TTK HEALTHCARE LIMITED
SKORE NOTHING Strawberry
In Commercial Distribution

  • 08906007135443 ()
  • 08906007135436 ()
  • 08906007135450 ()
  • 08906007135467 ()


  • Basic male condom, Hevea-latex

Brainlab Interface Rotating, with Marking - 04251269204715

No Description
Noras MRI products GmbH
01
In Commercial Distribution

  • 04251269204715 ()
113382

  • MRI system coil, radio-frequency

IDS WITH POWER SUPPLY UNIT - 04049098007610

No Description
DRAEGER MEDICAL SYSTEMS, INC.
7265130
In Commercial Distribution

  • 04049098007610 ()


  • Patient monitoring system module, interfacing

Vent Set COAX with Holder - 04048675026648

No Description
Drägerwerk AG & Co. KGaA
MP00316
Not in Commercial Distribution

  • 04048675026648 ()
  • 04048675422303 ()


  • Ventilator breathing circuit, single-use

Tru-Incise Valvulotome with Interchangeable Heads - H862TIVK2030NC0

Tru-Incise Valvulotome
URESIL, LLC
TIVK2030
Not in Commercial Distribution

  • H862TIVK2030NC2 ()
  • H862TIVK2030NC1 ()
  • H862TIVK2030NC0 ()

  • Length: 94 Centimeter
TIVK2030

  • Valvulotome, percutaneous

Tru-Incise Valvulotome with Interchangeable Heads - H862TIVK20300

Tru-Incise Valvulotome
URESIL, LLC
TIVK2030
Not in Commercial Distribution

  • H862TIVK20302 ()
  • H862TIVK20301 ()
  • H862TIVK20300 ()

  • Length: 94 Centimeter
TIVK2030

  • Vein stripper, single-use

Tru-Incise Valvulotome with Interchangeable Heads - H862TIVH40NC0

Tru-Incise 4mm Cutting Head
URESIL, LLC
TIVH40
Not in Commercial Distribution

  • H862TIVH40NC2 ()
  • H862TIVH40NC1 ()
  • H862TIVH40NC0 ()

  • Outer Diameter: 4 Millimeter
TIVH40

  • Valvulotome, percutaneous

Tru-Incise Valvulotome with Interchangeable Heads - H862TIVH400

Tru-Incise 4mm Cutting Head
URESIL, LLC
TIVH40
Not in Commercial Distribution

  • H862TIVH402 ()
  • H862TIVH401 ()
  • H862TIVH400 ()

  • Outer Diameter: 4 Millimeter
TIVH40

  • Vein stripper, single-use

Tru-Incise Valvulotome with Interchangeable Heads - H862TIVH30NC0

Tru-Incise 3mm Cutting Head
URESIL, LLC
TIVH30
Not in Commercial Distribution

  • H862TIVH30NC2 ()
  • H862TIVH30NC1 ()
  • H862TIVH30NC0 ()

  • Outer Diameter: 3 Millimeter
TIVH30

  • Valvulotome, percutaneous

Tru-Incise Valvulotome with Interchangeable Heads - H862TIVH300

Tru-Incise 3mm Cutting Head
URESIL, LLC
TIVH30
Not in Commercial Distribution

  • H862TIVH302 ()
  • H862TIVH301 ()
  • H862TIVH300 ()

  • Outer Diameter: 3 Millimeter
TIVH30

  • Vein stripper, single-use

Tru-Incise Valvulotome with Interchangeable Heads - H862TIVH20NC0

Tru-Incise 2mm Cutting Head
URESIL, LLC
TIVH20
Not in Commercial Distribution

  • H862TIVH20NC2 ()
  • H862TIVH20NC1 ()
  • H862TIVH20NC0 ()

  • Outer Diameter: 2 Micrometer
TIVH20

  • Valvulotome, percutaneous

Tru-Incise Valvulotome with Interchangeable Heads - H862TIVCNC0

Tru-Incise Valvulotome Catheter Kit
URESIL, LLC
TIVC
Not in Commercial Distribution

  • H862TIVCNC2 ()
  • H862TIVCNC1 ()
  • H862TIVCNC0 ()

  • Length: 94 Centimeter
TIVC

  • Valvulotome, percutaneous

Tru-Incise Valvulotome with Interchangeable Heads - H862TIVC0

Tru-Incise Valvulotome Catheter Kit
URESIL, LLC
TIVC
Not in Commercial Distribution

  • H862TIVC2 ()
  • H862TIVC1 ()
  • H862TIVC0 ()

  • Length: 94 Centimeter
TIVC

  • Vein stripper, single-use

TDX SP2 with LiNX Electronics - 00841447100911

No Description
INVACARE CORPORATION
TDXSP2
Not in Commercial Distribution

  • 00841447100911 ()


  • Electric-motor-driven wheelchair, occupant-controlled

BAYONETTE TURBINATE ELECTRODE WITH HP - 00841494102036

BAYONETTE TURBINATE ELECTRODE WITH HP
Cynosure, LLC
IEC-I6D
In Commercial Distribution

  • 00841494102036 ()
IEC-I6D

  • Open-surgery electrosurgical electrode, monopolar, reusable

LIGHT BOND SEALANT WITH FLOURIDE - D82813302100

No Description
FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC
1330210
In Commercial Distribution

  • D82813302100 ()


  • Orthodontic bracket adhesive

ic adapter with hexagon ball - 04048844124427

No Description
implantcast GmbH
75123608
In Commercial Distribution

  • 04048844124427 ()

  • 8mm


  • Orthopaedic implant-instrument extension adaptor, reusable

RETRACTOR CAWOOD-LIND MODIFIED WITH NOTCH - D928105532LM10

No Description
W.H. Holden, Inc.
10-5532LM-1
In Commercial Distribution

  • D928105532LM10 ()


  • Dental cheek retractor, professional, reusable

Mini Sheath with FlexCath Cross - 00850027837697

Mini sheath, 65cm – L2 with FlexCath Cross
ACUTUS MEDICAL, INC.
012852-005
In Commercial Distribution

  • 00850027837697 ()
012852-005

  • Cardiac transseptal access set

EXTRACTION FORCEPS #62 WITH SERRATIONS - D92810060006210

No Description
W.H. Holden, Inc.
10-0600-062-1
In Commercial Distribution

  • D92810060006210 ()


  • Tooth extraction forceps

OSMETTE XL with Barcode Reader - 00850041049762

Precision Systems OSMETTE XL with Barcode Reader
Precision Systems, Inc.
5007B
In Commercial Distribution

  • 00850041049762 ()
5007B

  • Osmometric analyser IVD

Sense System with IBT Electrodes - 00850004850480

Surface electrodes for Electromyography with Pattern Recognition controller - Michelangelo Hand with Axon Elbow
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
70101-24
In Commercial Distribution

  • 00850004850480 ()


  • Myoelectric hand prosthesis
  • Analytical non-scalp cutaneous electrode

Sense System with IBT Electrodes - 00850004850473

Surface electrodes for Electromyography with Pattern Recognition controller - Michelangelo Hand with Axon Wrist with Axon Elbow
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
70101-23
In Commercial Distribution

  • 00850004850473 ()


  • Myoelectric hand prosthesis
  • Analytical non-scalp cutaneous electrode

Sense System with IBT Electrodes - 00850004850466

Surface electrodes for Electromyography with Pattern Recognition controller - Michelangelo Hand with Axon Wrist
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
70101-22
In Commercial Distribution

  • 00850004850466 ()


  • Myoelectric hand prosthesis
  • Analytical non-scalp cutaneous electrode

Sense System with IBT Electrodes - 00850004850459

Surface electrodes for Electromyography with Pattern Recognition controller - Michelangelo Hand
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
70101-21
In Commercial Distribution

  • 00850004850459 ()


  • Myoelectric hand prosthesis
  • Analytical non-scalp cutaneous electrode

Sense System with IBT Electrodes - 00850004850442

Surface electrodes for Electromyography with Pattern Recognition controller - Espire Pro/Hybrid (Hand without grips without wrist)
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
70101-20
In Commercial Distribution

  • 00850004850442 ()


  • Myoelectric hand prosthesis
  • Analytical non-scalp cutaneous electrode

Sense System with IBT Electrodes - 00850004850411

Surface electrodes for Electromyography with Pattern Recognition controller - Espire Pro/Hybrid (Hand with grips without wrist) - Bebionic (Steeper)
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
70101-18-2
In Commercial Distribution

  • 00850004850411 ()


  • Myoelectric hand prosthesis
  • Analytical non-scalp cutaneous electrode

Sense System with IBT Electrodes - 00850004850404

Surface electrodes for Electromyography with Pattern Recognition controller - Espire Pro/Hybrid (Hand with grips without wrist) - TASKA
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
70101-18-1
In Commercial Distribution

  • 00850004850404 ()


  • Myoelectric hand prosthesis
  • Analytical non-scalp cutaneous electrode

Sense System with IBT Electrodes - 00850004850374

Surface electrodes for Electromyography with Pattern Recognition controller - Espire Pro/Hybrid (Hand with grips with wrist) - Bebionic (Steeper)
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
70101-17-2
In Commercial Distribution

  • 00850004850374 ()


  • Myoelectric hand prosthesis
  • Analytical non-scalp cutaneous electrode

Sense System with IBT Electrodes - 00850004850343

Surface electrodes for Electromyography with Pattern Recognition controller - E2 Elbow (Hand with grips without Wrist) - iLimb
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
70101-10-3
In Commercial Distribution

  • 00850004850343 ()


  • Myoelectric hand prosthesis
  • Analytical non-scalp cutaneous electrode

Sense System with IBT Electrodes - 00850004850336

Surface electrodes for Electromyography with Pattern Recognition controller - E2 Elbow (Hand with grips without Wrist) - Bebionic (Steeper)
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
70101-10-2
In Commercial Distribution

  • 00850004850336 ()


  • Myoelectric hand prosthesis
  • Analytical non-scalp cutaneous electrode

Sense System with IBT Electrodes - 00850004850329

Surface electrodes for Electromyography with Pattern Recognition controller - E2 Elbow (Hand with grips without Wrist) - TASKA
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
70101-10-1
In Commercial Distribution

  • 00850004850329 ()


  • Myoelectric hand prosthesis
  • Analytical non-scalp cutaneous electrode
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