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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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BEQ-HMOD 70000-USA Adult Quadrox iD, BO-VHK 71000 Venous Reservoir, BEQ-RF32 RotaFlow, Gas Filter.
DATASCOPE CORP.
BEQ-TOP 21902
Not in Commercial Distribution

  • 00607567203358 ()
701055522

  • Cardiopulmonary bypass system blood tubing set
Gas Sampling Line .060" ID x 120" Length PVCwith Male Luer Lock Connectors
SALTER LABS
ZML-9521-E-MSL-1
In Commercial Distribution

  • 10607411940429 ()
  • 00607411940422 ()
ZML-9521-E-MSL-1

  • Nasal oxygen cannula, carbon-dioxide-sampling
for post treatment, size 2 OD 10.0 mm, ID 9.0 mm, satin finished
Spiggle & Theis Medizintechnik GmbH
10-201-02
In Commercial Distribution

  • 04250676730466 ()
10-201-02

  • Ear speculum, reusable
for post treatment, size 1 OD 9.0 mm, ID 8.0 mm, satin finished
Spiggle & Theis Medizintechnik GmbH
10-201-01
In Commercial Distribution

  • 04250676730459 ()
10-201-01

  • Ear speculum, reusable
SHEPARD GROMMET VENT TUBE W/WIRE 1.14MM ID BLUE FLUOROPLASTIC/SS 30 PACK
Grace Medical, Inc.
525-123W
In Commercial Distribution

  • 00844505004183 ()
  • 10844505004180 ()


  • Tympanostomy tube
SHEPARD GROMMET VENT TUBE W/WIRE 1.14MM ID BLUE FLUOROPLASTIC / SS 5 PACK
Grace Medical, Inc.
525-121W
In Commercial Distribution

  • 00844505004169 ()
  • 10844505004166 ()


  • Tympanostomy tube
SHEPARD GROMMET VENT TUBE W/WIRE 1.02MM ID BLUE FLUOROPLASTIC / SS 5 PACK
Grace Medical, Inc.
525-111W
In Commercial Distribution

  • 00844505004138 ()
  • 10844505004135 ()


  • Tympanostomy tube
SHEPARD GROMMET VENT TUBE W/TAB 1.14MM ID BLUE FLUOROPLASTIC PAIR 60 PACK
Grace Medical, Inc.
525-046
In Commercial Distribution

  • 00844505004091 ()
  • 10844505004098 ()


  • Tympanostomy tube
REUTER BOBBIN VENT TUBE W/FLANGE HOLES 1.14 MM ID FLUOROPLASTIC 5 PACK
Grace Medical, Inc.
520-181
In Commercial Distribution

  • 00844505003971 ()
  • 10844505003978 ()


  • Tympanostomy tube
REUTER BOBBIN VENT TUBE WITH FLANGE HOLES 1.14MM ID BLUE TITANIUM 5 PACK
Grace Medical, Inc.
500-101
In Commercial Distribution

  • 00844505002615 ()
  • 10844505002612 ()


  • Tympanostomy tube
PARTIAL TILT TOP 3.50MM HEAD NOTCHED 1.12MM ID X 6MM L HA/OTOSIL
Grace Medical, Inc.
258
In Commercial Distribution

  • 00844505000406 ()


  • Ossicular prosthesis, partial
PARTIAL TILT TOP 4MM HEAD NOTCHED 1.12MM ID X 6MM L HA/OTOSIL
Grace Medical, Inc.
255
In Commercial Distribution

  • 00844505000376 ()


  • Ossicular prosthesis, partial
PARTIAL TILT TOP 4MM HEAD OFFSET 1.12MM ID X 6MM L HA/OTOSIL
Grace Medical, Inc.
253
In Commercial Distribution

  • 00844505000352 ()


  • Ossicular prosthesis, partial
PARTIAL TILT TOP 3.25MM HEAD OFFSET 1.12MM ID X 6MM L HA/OTOSIL
Grace Medical, Inc.
252
In Commercial Distribution

  • 00844505000345 ()


  • Ossicular prosthesis, partial
PARTIAL TILT TOP 4MM HEAD CENTERED 1.12MM ID X 6MM L HA/OTOSIL
Grace Medical, Inc.
251
In Commercial Distribution

  • 00844505000338 ()


  • Ossicular prosthesis, partial
TOUMA VENT TUBE W/ TAB 1.14 MM ID SILICONE, 50 DUROMETER 5 PACK
Grace Medical, Inc.
510-521
In Commercial Distribution

  • 00844505011679 ()
  • 10844505011676 ()


  • Tympanostomy tube
TOUMA VENT TUBE W/TAB 1.14MM ID PC SILICONE, 50 DUROMETER 5 PACK
Grace Medical, Inc.
510-521C
In Commercial Distribution

  • 00844505011570 ()
  • 10844505011577 ()


  • Tympanostomy tube
SHEEHY TYPE COLLAR BUTTON 1.27MM ID, 1.3MM INNER FLANGE - SILICONE PAIR 60 PACK
Grace Medical, Inc.
510-456
In Commercial Distribution

  • 00844505007979 ()
  • 10844505007976 ()


  • Tympanostomy tube
TRIUNE VENT TUBE 1.35MM ID X 5MM LENGTH SILICONE, 80 DUROMETER 5 PACK
Grace Medical, Inc.
510-331
In Commercial Distribution

  • 00844505007962 ()
  • 10844505007969 ()


  • Tympanostomy tube
ARMSTRONG R VENT TUBE W/ TAB 1.14MM ID - PC SILICONE PAIR 60 PACK
Grace Medical, Inc.
510-286C
In Commercial Distribution

  • 00844505007870 ()
  • 10844505007877 ()


  • Tympanostomy tube
ARMSTRONG R VENT TUBE W/TAB 1.14 MM ID SILICONE PAIR 10 PACK
Grace Medical, Inc.
510-282
In Commercial Distribution

  • 00844505007856 ()
  • 10844505007853 ()


  • Tympanostomy tube
CATHETER EZ STEER BI-DIRECTIONAL CS DEFECTABLE CURVE TYPE: F-J 12 PIN AUTO ID
STERILMED, INC.
BIOBD710FJ282CT
In Commercial Distribution

  • 10888551005944 ()
BIOBD710FJ282CT

  • Cardiac mapping catheter, percutaneous, reprocessed
CATHETER EZ STEER BI-DIRECTIONAL CS DEFLECTABLE CURVE TYPE: D-F 12 PIN AUTO ID
STERILMED, INC.
BIOBD710DF282CT
In Commercial Distribution

  • 10888551005920 ()
BIOBD710DF282CT

  • Cardiac mapping catheter, percutaneous, reprocessed
GAS SAMPLE LINE, .047" ID x 120" Length PE/PVC Male/Female connector
SALTER LABS
ZML-9640B-125
In Commercial Distribution

  • 10607411401357 ()
  • 00607411401350 ()
ZML-9640B-125

  • Nasal oxygen cannula, carbon-dioxide-sampling
Gas Sampling Line .050" ID x 120" Length PVCMale/Female Luer Lock Connectors
SALTER LABS
ZML-9630-1
Not in Commercial Distribution

  • 10607411911689 ()
  • 00607411911682 ()
ZML-9630-1

  • Nasal oxygen cannula, carbon-dioxide-sampling
Gas Sampling Line .060" ID x 120" Length PVCMale/Female Luer Lock Connectors
SALTER LABS
ZML-9620-1
Not in Commercial Distribution

  • 10607411911665 ()
  • 00607411911668 ()
ZML-9620-1

  • Nasal oxygen cannula, carbon-dioxide-sampling
Gas Sampling Line .060" ID x 120" Length PVCwith Male Luer Lock Connectors
SALTER LABS
ZML-9520-1
Not in Commercial Distribution

  • 10607411911658 ()
  • 00607411911651 ()
ZML-9520-1

  • Nasal oxygen cannula, carbon-dioxide-sampling
CAUSSE PISTON 6.0 MM FUNCTIONAL LENGTH 0.4 MM DIA 0.6 MM ID FLUOROPLASTIC
Gyrus ACMI, LLC
140457
In Commercial Distribution

  • 00821925017290 ()


  • Ossicular prosthesis, partial
SHEPARD GROMMET VENT TUBE PACIFIC 1.02 MM ID FLOUROPLASTIC, PC COATED (30/PK)
Gyrus ACMI, LLC
70141031
In Commercial Distribution

  • 00821925024663 ()
  • 00821925033962 ()


  • Tympanostomy tube
ARMSTRONG V TYPE VENT TUBE STRAIGHT, BLUE 1.14MM ID 7.5MM LENGTH FLUOROPLASTIC PASCIFIC
Gyrus ACMI, LLC
70140401
In Commercial Distribution

  • 00821925020252 ()
  • 00821925032835 ()


  • Tympanostomy tube
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