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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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Straumann BLX Line Extension - New Abutments - 07630031740625

Custom Abutment CoCr, RB/WB, TAN screw
Institut Straumann AG
Final Abutments
In Commercial Distribution

  • 07630031740625 ()
010.6143

  • Dental implant suprastructure, permanent, preformed

Cellfina Motor Module Device and Package - 00840763100384

No change in DI justified in the CO. No form fit function, model or version changes triggering a new DI
Ulthera, Inc.
CM1 Rev C, D, E
In Commercial Distribution

  • 00840763100384 ()


  • Mechanical skin contouring system motor

NIBP Cuffs - 20884838008551

Neonatal Single-Patient Size #4, Circ: 7.1 - 13.1 cm, incorporates the new connector configuration, replaces the M1872A, 40 cuffs per box.
Philips Medical Systems Hsg
NEONATAL SINGLE-PATIENT CUFF SIZE #4
Not in Commercial Distribution

  • 20884838008551 ()
  • 00884838008557 ()

  • Circumference: 13.1 Centimeter
M1872B

  • Blood pressure cuff, reusable

NIBP Cuffs - 20884838008537

Neonatal Single-Patient Size #3, Circ: 5.8 - 10.9 cm, incorporates the new connector configuration, replaces the M1870A, 40 cuffs per box.
Philips Medical Systems Hsg
NEONATAL SINGLE-PATIENT CUFF SIZE #3
Not in Commercial Distribution

  • 20884838008537 ()
  • 00884838008533 ()

  • Circumference: 10.9 Centimeter
M1870B

  • Blood pressure cuff, reusable

NIBP Cuffs - 20884838008513

Neonatal Single-Patient Size #2, Circ: 4.3 - 8.0 cm, incorporates the new connector configuration, replaces the M1868A, 40 cuffs per box.
Philips Medical Systems Hsg
NEONATAL SINGLE-PATIENT CUFF SIZE #2
Not in Commercial Distribution

  • 20884838008513 ()
  • 00884838008519 ()

  • Circumference: 8 Centimeter
M1868B

  • Blood pressure cuff, reusable

EVA SELECT DIRECT - D83399924132050

EVA SELECT DIRECT SIZE 2 SENSOR ONLY
ImageWorks
9992413205
In Commercial Distribution

  • D83399924132050 ()
9992413205

  • General-purpose dental x-ray system application software
  • Dental digital imaging sensor, intraoral

EVA SELECT DIRECT - D83399924131050

EVA SELECT DIRECT SIZE 1 SENSOR ONLY
ImageWorks
9992413105
In Commercial Distribution

  • D83399924131050 ()
9992413105

  • General-purpose dental x-ray system application software
  • Dental digital imaging sensor, intraoral

EVA SELECT DIRECT - D83399924131000

EVA SELECT DIRECT SIZE 1 SYSTEM
ImageWorks
9992413100
In Commercial Distribution

  • D83399924131000 ()
9992413100

  • General-purpose dental x-ray system application software
  • Dental digital imaging sensor, intraoral

EVA SELECT - D83399924122000

EVA SELECT SIZE 2 SYSTEM
ImageWorks
9992412200
In Commercial Distribution

  • D83399924122000 ()
9992412200

  • General-purpose dental x-ray system application software
  • Dental digital imaging sensor, intraoral

EVA SELECT - D83399924121000

EVA SELECT SIZE 1 SYSTEM
ImageWorks
9992412100
In Commercial Distribution

  • D83399924121000 ()
9992412100

  • Dental digital imaging sensor, intraoral
  • General-purpose dental x-ray system application software
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