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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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U2™ Hip - 04719872161097

XPE cup liner trial, ID 28mm, 10°x46mm
UNITED ORTHOPEDIC CORP.
1403-2046
In Commercial Distribution

  • 04719872161097 ()

  • ID 28mm, 10°x46mm
1403-2046

  • Acetabulum prosthesis trial, prefabricated, reusable

U2™ Hip - 04719872161080

XPE cup liner trial, ID 28mm, 10°x44mm
UNITED ORTHOPEDIC CORP.
1403-2044
In Commercial Distribution

  • 04719872161080 ()

  • ID 28mm, 10°x44mm
1403-2044

  • Acetabulum prosthesis trial, prefabricated, reusable

Ontrak - 10841522129254

CUFF,ABP,ADULT,L,32-42CM/13-17IN,NO LTX
SPACELABS HEALTHCARE (WASHINGTON), INC
ABP Cuffs and Cuff Covers
In Commercial Distribution

  • 10841522129254 ()

  • 32 cm-42 cm ID
016-0077-06Q

  • Blood pressure ambulatory recorder

Ontrak - 10841522129247

CUFF,ABP,CHILD,12-20CM/5-8IN,NO LTX
SPACELABS HEALTHCARE (WASHINGTON), INC
ABP Cuffs and Cuff Covers
In Commercial Distribution

  • 10841522129247 ()

  • 12-20 cm/5-8in ID
015-0118-05Q

  • Blood pressure ambulatory recorder

Ontrak - 10841522129230

CUFF,ABP,ADULT M,24-32CM/9-13IN,NO LTX
SPACELABS HEALTHCARE (WASHINGTON), INC
ABP Cuffs and Cuff Covers
In Commercial Distribution

  • 10841522129230 ()

  • 24-32 cm/ 9-13 " ID
015-0068-06Q

  • Blood pressure ambulatory recorder

Ontrak - 10841522129223

CUFF,ABP,ADULT,S,17-26CM/7-10IN,NO LTX
SPACELABS HEALTHCARE (WASHINGTON), INC
ABP Cuffs and Cuff Covers
In Commercial Distribution

  • 10841522129223 ()

  • 28 cm/ 7-10" ID
015-0067-05Q

  • Blood pressure ambulatory recorder

Ontrak - 10841522123870

ABP CUFF,SPACELABS,1T,XLADULT,SPU,20/BX
Statcorp Medical
ABP Cuffs and Cuff Covers
In Commercial Distribution

  • 10841522123870 ()

  • 42 cm-50 cm ID
015-4250-00

  • Blood pressure cuff, single-use

NeuraGen® - 10381780071860

NeuraGen® Nerve Guide 7mm (ID) X 2cm (Length)
Integra Lifesciences Corporation
PNG720
In Commercial Distribution

  • 10381780071860 ()
  • M269PNG7201 ()

  • 7mm (ID) x2cm (Length)
PNG-720

  • Nerve guide, animal-derived

NeuraGen® - 10381780071853

NeuraGen® Nerve Guide 6mm (ID) X 2cm (Length)
Integra Lifesciences Corporation
PNG620
In Commercial Distribution

  • 10381780071853 ()
  • M269PNG6201 ()

  • 6mm (ID) x2cm (Length)
PNG-620

  • Nerve guide, animal-derived

NeuraGen® - 10381780071822

NeuraGen® Nerve Guide 1.5mm (ID) X 3cm (Length)
Integra Lifesciences Corporation
PNG130
In Commercial Distribution

  • 10381780071822 ()
  • M269PNG1301 ()

  • 1.5mm (ID) x3cm (Length)
PNG-130

  • Nerve guide, animal-derived

NeuraGen® - 10381780026518

NeuraGen® Nerve Guide 5mm (ID) X 3cm (Length)
Integra Lifesciences Corporation
PNG530
In Commercial Distribution

  • 10381780026518 ()
  • M269PNG5301 ()

  • 5mm (ID) x3cm (Length)
PNG-530

  • Nerve guide, animal-derived

CUSA® Excel - 10381780025924

CUSA® Excel 23kHz 1.98mm Curved Extended Standard Tip
INTEGRA LIFESCIENCES (IRELAND) LIMITED
C4603S
In Commercial Distribution

  • 30381780025928 ()
  • 10381780025924 ()
  • M269C4603S15 ()

  • 1.98mm ID; 23kHz frequency
C4603S

  • Soft-tissue ultrasonic surgical system handpiece tip, single-use

CUSA® Excel - 10381780025917

CUSA® Excel 23kHz 1.98mm Straight Extended Standard Tip
INTEGRA LIFESCIENCES (IRELAND) LIMITED
C4602S
In Commercial Distribution

  • 30381780025911 ()
  • 10381780025917 ()
  • M269C4602S14 ()

  • 1.98mm ID; 23kHz frequency
C4602S

  • Soft-tissue ultrasonic surgical system handpiece tip, single-use

N.A. - J011602839550

Variety click SP Mini - 8, straight / Monoguided special expansion screw with click feature to prevent unwanted reversing / For further information please visit our online-
DENTAURUM GmbH & Co.KG
602-839-55
In Commercial Distribution

  • J011602839550 ()
  • J011602839551 ()


  • Orthodontic palate expander screw, bonded

N.A. - J011602838550

Variety click SP Mini - 8, straight / Monoguided special expansion screw with click feature to prevent unwanted reversing / For further information please visit our online-
DENTAURUM GmbH & Co.KG
602-838-55
In Commercial Distribution

  • J011602838550 ()
  • J011602838551 ()


  • Orthodontic palate expander screw, bonded

FB - 03573026099923

FB is a reagent associated to API® Campy (20 800), ID 32 STAPH (32 500), rapid ID 32 A (32 300), rapid ID 32 STREP (32 600)
BIOMERIEUX SA
70562
In Commercial Distribution

  • 03573026099923 ()


  • Multiple Staphylococcus bacterial species culture isolate identification IVD, kit

BeamSite - 00860009184503

BeamSite™ is a camera system that enables live visualization of the treatment beam on a patient during radiotherapy. It is an optically based system that is non-patient contacting and produces no radiation. When the treatment beam is on, BeamSite captures images of Cherenkov light emitted from the patient’s skin during radiotherapy to provide an optical map of the treatment beam on the patient. When the treatment beam is off, the system provided continuous background images of the treatment area under ambient light illumination. The BeamSite system consists of a camera, a workstation with preinstalled BeamSite software, and a monitor to be used by clinical radiotherapy teams to a) visually observe the patient and the Cherenkov light emitted from irradiated surface anatomy, and b) review the treatment images, if necessary.
Doseoptics LLC
BeamSite
In Commercial Distribution

  • 00860009184503 ()


  • Radiation therapy software
  • Radiation therapy system workstation, multi-purpose

AirLife™ - 10190752145283

AirLife™ Ventilator Elbow with Suction Port and Cap 22 mm ID Inlet Arm, 15 mm ID Base
VYAIRE MEDICAL, INC.
001551
In Commercial Distribution

  • 50190752145281 ()
  • 10190752145283 ()
001551

  • Straight/elbow breathing circuit connector, single-use

N/AN/A - 00884908104301

3F (1.1MM ID) X 3CM3F (1.1MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/60CM STAINLESS STEEL WIREW/60C & 22GA NEEDLE
Medical Components, Inc.
MR1903622
Not in Commercial Distribution

  • 30884908104302 ()
  • 00884908104301 ()
  • 50884908104306 ()
MR1903622

  • Vascular catheter introduction needle

N/AN/A - 00884908104202

2F (0.7MM ID) X 2CM2F (0.7MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/60CM STAINLESS STEEL WIREW/60C & 22GA NEEDLE
Medical Components, Inc.
MR1902622
Not in Commercial Distribution

  • 30884908104203 ()
  • 00884908104202 ()
  • 50884908104207 ()
MR1902622

  • Vascular catheter introduction needle

EPI-DERM - 00852260000128

Natural Fabric Areopexy 2.75" OD x .75 ID x 5.90" L (6.9cm OD x 1.9cm ID) 1 Pair
Biodermis LLC
FLP-1
In Commercial Distribution

  • 00852260000128 ()
FLP-1

  • Scar-management dressing, reusable

EPI-DERM - 00852260000111

Natural Fabric Areopexy 2.75" OD x .75 ID x 5.90" L (6.9cm OD x 1.9cm ID) 5 Pair
Biodermis LLC
FLP-51
In Commercial Distribution

  • 00852260000111 ()
FLP-51

  • Scar-management dressing, reusable

VP A + VP B - 03573026099947

VPA VPB is a reagent associated to ID 32 STAPH (32 500) & rapid ID 32 STREP (32 600)
BIOMERIEUX SA
70572
In Commercial Distribution

  • 03573026099947 ()


  • Multiple Staphylococcus bacterial species culture isolate identification IVD, kit

NA - 10620974001673

MDI Adaptor for use with or without dosage counters - 15mm OD x 15mm ID (Flow OD to ID)
Southmedic Incorporated
SMDIA-1300
In Commercial Distribution

  • 10620974001673 ()
  • 00620974001676 ()

  • MDI Adaptor for use with or without dosage counters - 15mm OD x 15mm ID (Flow OD to ID)
SMDIA-1300

  • Inhalation-therapy adaptor, single-use

BE 105-2X22 Adapter - M996BE1052X220

General Adapter - 22mm ID x 22mm ID adapter for use in breathing/ventilator circuit. Molded of polycarbonate. Reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 105-2X22
In Commercial Distribution

  • M996BE1052X224 ()
  • M996BE1052X220 ()
  • M996BE1052X221 ()
BE 105-2X22

  • Straight/elbow breathing circuit connector, reusable

BE 101-00-3443 Straight Connector - M996BE1010034430

Straight Connector - 22mm ID x 22mm ID. Fits components of adult ventilator circuits. Molded of silicone rubber. Reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 101-00-3443
In Commercial Distribution

  • M996BE1010034435 ()
  • M996BE1010034430 ()
  • M996BE1010034432 ()
BE 101-00-3443

  • Straight/elbow breathing circuit connector, reusable

BE 101-00-1426 Tapered Connector - M996BE1010014260

Tapered Connector - 22mm ID x 27mm ID. Fits components of adult ventilator circuits. Molded of silicone rubber. Reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 101-00-1426
In Commercial Distribution

  • M996BE1010014265 ()
  • M996BE1010014260 ()
  • M996BE1010014262 ()
BE 101-00-1426

  • Straight/elbow breathing circuit connector, reusable

PF 1515 Straight Silicone Rubber Connector - M996PF15150

Straight Connector - 15mm ID x 15mm ID. Fits components of pediatric ventilator circuits. Molded of silicone rubber. Reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
PF 1515
In Commercial Distribution

  • M996PF15152 ()
  • M996PF15150 ()
  • M996PF15155 ()
PF 1515

  • Straight/elbow breathing circuit connector, reusable

PF 1010 Straight Silicone Rubber Connector - M996PF10100

Straight Connector - 10mm ID x 10mm ID. Fits components of neonatal ventilator circuits. Molded of silicone rubber. Reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
PF 1010
In Commercial Distribution

  • M996PF10102 ()
  • M996PF10100 ()
  • M996PF10105 ()
PF 1010

  • Straight/elbow breathing circuit connector, reusable

PF 001 Reducing Silicone Rubber Connector - M996PF0010

Reducing Connector - 22mm ID x 15mm ID. Fits components of adult ventilator circuits. Molded of silicone rubber. Reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
PF 001
In Commercial Distribution

  • M996PF0012 ()
  • M996PF0010 ()
  • M996PF0015 ()
PF 001

  • Straight/elbow breathing circuit connector, reusable
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