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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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Surgical Direct - B382SD1465610020

7" Michele Trephine, Large, OD 7mm, ID 6mm
Surgical Direct, Inc.
SD14656-1002
In Commercial Distribution

  • B382SD1465610020 ()
SD14656-1002

  • Orthopaedic osteotome

Surgical Direct - B382SD1465610010

7" Michele Trephine, Medium, OD 5mm, ID 4mm
Surgical Direct, Inc.
SD14656-1001
In Commercial Distribution

  • B382SD1465610010 ()
SD14656-1001

  • Orthopaedic osteotome

Surgical Direct - B382SD1465610000

7" Michele Trephine, Small, OD 4mm, ID 3mm
Surgical Direct, Inc.
SD14656-1000
In Commercial Distribution

  • B382SD1465610000 ()
SD14656-1000

  • Orthopaedic osteotome

Fungal Serology - 10634853000107

Histoplasma capsulatum Antigen (H&M), 2mL ID/EXO
MICROBIOLOGICS INC.
200245
Not in Commercial Distribution

  • 10634853000107 ()
200245

  • Histoplasma capsulatum exoantigen IVD, control

PROCARE - 00888912399135

XCELTRAX AIR, X-LARGE, NORTH ID FOOT AND ANKLE
DJO, LLC
79-95518-0100
In Commercial Distribution

  • 00888912399135 ()


  • Ankle/foot orthosis

PROCARE - 00888912398978

XCELTRAX AIR, LARGE, NORTH ID FOOT AND ANKLE
DJO, LLC
79-95517-0100
In Commercial Distribution

  • 00888912398978 ()


  • Ankle/foot orthosis

PROCARE - 00888912398817

XCELTRAX, AIR, MEDIUM, NORTH ID FOOT AND ANKLE
DJO, LLC
79-95515-0100
In Commercial Distribution

  • 00888912398817 ()


  • Ankle/foot orthosis

PROCARE - 00888912398657

XCELTRAX AIR, SMALL, NORTH ID FOOT AND ANKLE
DJO, LLC
79-95513-0100
In Commercial Distribution

  • 00888912398657 ()


  • Ankle/foot orthosis

truSculpt 40 Hand Held - 00816722022455

truSculpt 40 Hand Held RF Handpiece for iD
CUTERA, INC.
truSculpt 40 Hand Held
In Commercial Distribution

  • 00816722022455 ()


  • Radio-frequency skin contouring system applicator, monopolar

truSculpt 16 Hand Held - 00816722022448

truSculpt 16 Hand Held RF Handpiece for iD
CUTERA, INC.
truSculpt 16 Hand Held
In Commercial Distribution

  • 00816722022448 ()


  • Radio-frequency skin contouring system applicator, monopolar
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