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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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ITL Dental - 00817686024394

LS Latch to Square Driver
EMERY ENTERPRISES INC
LS
In Commercial Distribution

  • 00817686024394 ()


  • Screw endosteal dental implant, two-piece

SYSTEM 83 PLUS - SYSTEM83PLUS9

A device to disinfect endoscopes
Wassenburg Medical, Inc.
SYSTEM 83 PLUS 9
Not in Commercial Distribution

  • SYSTEM83PLUS9 ()
  • B21583PLUS9 ()


  • Endoscope washer-disinfector (chemical)

Storage Cabinet - STORAGECABINET20000

A device to store endoscopes.
Wassenburg Medical, Inc.
20000
Not in Commercial Distribution

  • B215STORAGECABINET20000 ()
  • STORAGECABINET20000 ()


  • Endoscope drying/storage cabinet

SYSTEM 83 PLUS - SYSTEM83PLUS2

A device to disinfect endoscopes
Wassenburg Medical, Inc.
SYSTEM 83 PLUS 2
Not in Commercial Distribution

  • SYSTEM83PLUS2 ()
  • B21583PLUS2 ()


  • Endoscope washer-disinfector (chemical)

Drive Rail System - 00817867020658

SCREW, SHORT, CLAMP TO CARRIAGE
ORTHOPEDIATRICS CORP.
22-3507
In Commercial Distribution

  • 00817867020658 ()
22-3507

  • External orthopaedic fixation system noninvasive component, single-use

Drive Rail - 00817867020313

Screw, Short, Clamp To Carriage
ORTHOPEDIATRICS CORP.
20-3507
Not in Commercial Distribution

  • 00817867020313 ()
20-3507

  • External orthopaedic fixation system, single-use

SOLACE Sacroiliac Fixation System - 00818345029392

Pin to pin connector, 22mm
XENIX MEDICAL LLC
SS1-A2-000722
In Commercial Distribution

  • 00818345029392 ()
SS1-A2-000722

  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit

SOLACE Sacroiliac Fixation System - 00818345029385

Pin to pin connector, 20mm
XENIX MEDICAL LLC
SS1-A2-000720
In Commercial Distribution

  • 00818345029385 ()
SS1-A2-000720

  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit

SOLACE Sacroiliac Fixation System - 00818345029378

Pin to pin connector, 18mm
XENIX MEDICAL LLC
SS1-A2-000718
In Commercial Distribution

  • 00818345029378 ()
SS1-A2-000718

  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit

SOLACE Sacroiliac Fixation System - 00818345029361

Pin to pin connector, 16mm
XENIX MEDICAL LLC
SS1-A2-000716
In Commercial Distribution

  • 00818345029361 ()
SS1-A2-000716

  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
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