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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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Fascile Continuous Peripheral Nerve Block Set - B372500001011

Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit is a needle comprised of an open tip catheter over a needle. Fascile kit is comprised of different key components required to complete the Peripheral Nerve Block procedure.
Solo-Dex, Inc
70mm, Kit with filter
Not in Commercial Distribution

  • B3723000301015 ()
  • B372500001011 ()
  • B3721001385 ()

  • Length: 70 Millimeter
500001-01

  • Peripheral nerve-block sharp needle

I.CO.S® - 10381780051831

The cannulated internal tap is designed to prepare the thread of the 4mm compression screw heads. It is introduced through the protecting sleeve and screwed into the countersink area intended for the screw head and then gently unscrewed.
NEWDEAL
119525ND
Not in Commercial Distribution

  • M248119525ND1 ()
  • 10381780051831 ()

  • 1.8mm inner/6mm outer diameter X 165mm length


  • Bone tap, reusable

Probe, 405 Blue-Vio, labeled, US - B3926001400

The Scalar Wave Laser System is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
STELLAR LASERS LLC
600140
In Commercial Distribution

  • B3926001400 ()


  • Musculoskeletal/physical therapy laser, home-use

Probe, 780 IR, labeled, US - B3926001300

The Scalar Wave Laser System is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
STELLAR LASERS LLC
600130
In Commercial Distribution

  • B3926001300 ()


  • Musculoskeletal/physical therapy laser, home-use

Probe, 650 Red, labeled, US - B3926001200

The Scalar Wave Laser System is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
STELLAR LASERS LLC
600120
In Commercial Distribution

  • B3926001200 ()


  • Musculoskeletal/physical therapy laser, home-use

SWL, Silver, labeled, US - B3926001100

The Scalar Wave Laser System is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
STELLAR LASERS LLC
600110
In Commercial Distribution

  • B3926001100 ()


  • Musculoskeletal/physical therapy laser, home-use

SWL, Violet, labeled, US - B3926001000

The Scalar Wave Laser System is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
STELLAR LASERS LLC
600100
In Commercial Distribution

  • B3926001000 ()


  • Musculoskeletal/physical therapy laser, home-use

Total Triiodothyronine T3 ELISA (Total T3 ELISA) - B24225TRIHUE010

The Total Triiodothyronine T3 ELISA (Total T3 ELISA) is intended for use in the quantitative determination of triiodothyronine (T3) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
25-TRIHU-E01
Not in Commercial Distribution

  • B24225TRIHUE010 ()
25-TRIHU-E01

  • Total triiodothyronine (TT3) IVD, kit, enzyme immunoassay (EIA)

Human Chorionic Gonadotropin ELISA - B24225HCGHUE010

The Human Chorionic Gonadotropin ELISA is intended for use in the quantitative determination of human chorionic gonadotropin (hCG) concentration in human serum. The assay is for use in the early diagnosis of pregnancy in a clinical laboratory setting.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
25-HCGHU-E01
Not in Commercial Distribution

  • B24225HCGHUE010 ()
25-HCGHU-E01

  • Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA)

Langston® dual lumen catheter - M20655500

Each LANGSTON dual lumen catheter is indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressure measurement is useful in determining transvalvular, intravascular and intraventricular pressure gradients.
Vascular Solutions, Inc.
5550
Not in Commercial Distribution

  • M20655500 ()
  • M20655501 ()

  • Catheter Gauge: 6 French


  • Angiographic catheter, single-use
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