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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Biopsy Punch, 5mm with Tooth with Ratchet Handle: 8511-01 Standard Composite, 30cm Length
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
8517-02-30-R/8511-01
In Commercial Distribution

  • 00848657063517 ()


  • Rigid endoscopic tissue manipulation forceps, reusable
Biopsy Punch, 5mm with Tooth with Ratchet Handle: 8511-01 Standard Composite, 26cm Length
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
8517-02-26-R/8511-01
In Commercial Distribution

  • 00848657063401 ()


  • Rigid endoscopic tissue manipulation forceps, reusable
CASTROVIEJO NEEDLE HOLDER WITH SCISSORS WITH LOCK CURVED TUNGSTEN CARBIDE INSERT FLAT HANDLE
SONTEC INSTRUMENTS, INC.
15-1982
In Commercial Distribution

  • 00192896017740 ()

  • Length: 5.5 Inch
15-1982

  • Suturing needle holder, reusable
CASTROVIEJO NEEDLE HOLDER WITH SCISSORS WITH LOCK STRAIGHT TUNGSTEN CARBIDE INSERT FLAT HANDLE
SONTEC INSTRUMENTS, INC.
15-1980
In Commercial Distribution

  • 00192896017733 ()

  • Length: 5.5 Inch
15-1980

  • Suturing needle holder, reusable
MICTEC HF SUCTION ELECTRODE WITH LATERAL SLOTS CURVED DOWN, WITH STRAIGHT SUCTION VALVE
SONTEC INSTRUMENTS, INC.
20947-11-012
In Commercial Distribution


  • 7mm 30° Tip
  • Length: 300 Millimeter


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
MICTEC HF FLAT ELECTRODE WITH LATERAL SLOTS CURVED WITH CONNECTOR TO SUCTION-IRRIGATION VALVES
SONTEC INSTRUMENTS, INC.
20947-11-003
In Commercial Distribution


  • 7mm 30° Tip
  • Length: 300 Millimeter
  • 10mm Valve Connection


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Additional Extra-Long Inner Cannula, Fenestrated, with Speaking Valve, with additional oxygen supply port
Tracoe medical GmbH
REF 888-204-08IK-O
Not in Commercial Distribution

  • 04035324032204 ()

  • Lumen/Inner Diameter: 6.7 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use
Extra-Long Tube, with Swivel Speaking Valve, Type B, with additional oxygen supply port
Tracoe medical GmbH
REF 888-204-10N-O
Not in Commercial Distribution

  • 04035324025978 ()

  • Lumen/Inner Diameter: 8.8 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use
Extra-Long Tube, with Swivel Speaking Valve, Type B, with additional oxygen supply port
Tracoe medical GmbH
REF 888-204-09N-O
Not in Commercial Distribution

  • 04035324025886 ()

  • Lumen/Inner Diameter: 7.5 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use
Extra-Long Tube, with Swivel Speaking Valve, Type B, with additional oxygen supply port
Tracoe medical GmbH
REF 888-204-08N-O
Not in Commercial Distribution

  • 04035324025794 ()

  • Lumen/Inner Diameter: 6.7 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use
Extra-Long Tube, with Swivel Speaking Valve, Type B, with additional oxygen supply port
Tracoe medical GmbH
REF 888-204-05N-O
Not in Commercial Distribution

  • 04035324025534 ()

  • Lumen/Inner Diameter: 4.0 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use
Extra-Long Tube, with Slide-On Speaking Valve, Type A, with additional oxygen supply port
Tracoe medical GmbH
REF 888-203-14N-O
Not in Commercial Distribution

  • 04035324025442 ()

  • Lumen/Inner Diameter: 12.6 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use
Extra-Long Tube, with Slide-On Speaking Valve, Type A, with additional oxygen supply port
Tracoe medical GmbH
REF 888-203-13N-O
Not in Commercial Distribution

  • 04035324025381 ()

  • Lumen/Inner Diameter: 11.8 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use
Extra-Long Tube, with Slide-On Speaking Valve, Type A, with additional oxygen supply port
Tracoe medical GmbH
REF 888-203-12N-O
Not in Commercial Distribution

  • 04035324025336 ()

  • Lumen/Inner Diameter: 10.0 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use
Extra-Long Tube, with Slide-On Speaking Valve, Type A, with additional oxygen supply port
Tracoe medical GmbH
REF 888-203-11N-O
Not in Commercial Distribution

  • 04035324025275 ()

  • Lumen/Inner Diameter: 9.2 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use
Extra-Long Tube, with Slide-On Speaking Valve, Type A, with additional oxygen supply port
Tracoe medical GmbH
REF 888-203-10N-O
Not in Commercial Distribution

  • 04035324025220 ()

  • Lumen/Inner Diameter: 8.8 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use
Extra-Long Tube, with Slide-On Speaking Valve, Type A, with additional oxygen supply port
Tracoe medical GmbH
REF 888-203-09N-O
Not in Commercial Distribution

  • 04035324025176 ()

  • Lumen/Inner Diameter: 7.5 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use
Tube, Fenestrated, with Swivel Speaking Valve, Type B, with additional oxygen supply port
Tracoe medical GmbH
REF 888-104-14-O
Not in Commercial Distribution

  • 04035324022731 ()

  • Lumen/Inner Diameter: 12.6 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use
Tube, Fenestrated, with Swivel Speaking Valve, Type B, with additional oxygen supply port
Tracoe medical GmbH
REF 888-104-13-O
Not in Commercial Distribution

  • 04035324022649 ()

  • Lumen/Inner Diameter: 11.8 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use
Tube, Fenestrated, with Swivel Speaking Valve, Type B, with additional oxygen supply port
Tracoe medical GmbH
REF 888-104-12-O
Not in Commercial Distribution

  • 04035324022557 ()

  • Lumen/Inner Diameter: 10.8 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use
Tube, Fenestrated, with Swivel Speaking Valve, Type B, with additional oxygen supply port
Tracoe medical GmbH
REF 888-104-11-O
Not in Commercial Distribution

  • 04035324022472 ()

  • Lumen/Inner Diameter: 9.7 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use
Tube, Fenestrated, with Swivel Speaking Valve, Type B, with additional oxygen supply port
Tracoe medical GmbH
REF 888-104-10-O
Not in Commercial Distribution

  • 04035324022380 ()

  • Lumen/Inner Diameter: 8.7 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use
Extra-Long Tube, with Swivel Speaking Valve, Type B, with additional oxygen supply port
Tracoe medical GmbH
REF 888-204-14N-O
Not in Commercial Distribution

  • 04035324026333 ()

  • Lumen/Inner Diameter: 12.6 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use
Extra-Long Tube, with Swivel Speaking Valve, Type B, with additional oxygen supply port
Tracoe medical GmbH
REF 888-204-13N-O
Not in Commercial Distribution

  • 04035324026241 ()

  • Lumen/Inner Diameter: 11.8 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use
Extra-Long Tube, with Swivel Speaking Valve, Type B, with additional oxygen supply port
Tracoe medical GmbH
REF 888-204-12N-O
Not in Commercial Distribution

  • 04035324026159 ()

  • Lumen/Inner Diameter: 10.0 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use
Extra-Long Tube, with Swivel Speaking Valve, Type B, with additional oxygen supply port
Tracoe medical GmbH
REF 888-204-11N-O
Not in Commercial Distribution

  • 04035324026067 ()

  • Lumen/Inner Diameter: 9.2 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use
Extra-Long Tube, with Swivel Speaking Valve, Type B, with additional oxygen supply port
Tracoe medical GmbH
REF 888-204-07N-O
Not in Commercial Distribution

  • 04035324025701 ()

  • Lumen/Inner Diameter: 6.0 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use
Extra-Long Tube, with Swivel Speaking Valve, Type B, with additional oxygen supply port
Tracoe medical GmbH
REF 888-204-06N-O
Not in Commercial Distribution

  • 04035324025626 ()

  • Lumen/Inner Diameter: 5.0 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use
Extra-Long Tube, with Slide-On Speaking Valve, Type A, with additional oxygen supply port
Tracoe medical GmbH
REF 888-203-08N-O
Not in Commercial Distribution

  • 04035324025121 ()

  • Lumen/Inner Diameter: 6.7 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use
Extra-Long Tube, with Slide-On Speaking Valve, Type A, with additional oxygen supply port
Tracoe medical GmbH
REF 888-203-07N-O
Not in Commercial Distribution

  • 04035324025060 ()

  • Lumen/Inner Diameter: 6.0 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use
Extra-Long Tube, with Slide-On Speaking Valve, Type A, with additional oxygen supply port
Tracoe medical GmbH
REF 888-203-06N-O
Not in Commercial Distribution

  • 04035324025008 ()

  • Lumen/Inner Diameter: 5.0 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use
Extra-Long Tube, with Slide-On Speaking Valve, Type A, with additional oxygen supply port
Tracoe medical GmbH
REF 888-203-05N-O
Not in Commercial Distribution

  • 04035324024957 ()

  • Lumen/Inner Diameter: 4.0 Millimeter


  • Tracheostomy tube, non-reinforced, non-customized, single-use
Beam Splitter, HD with camera, with HDMI/DVI output, for OP-C12 and OP-C16
BR Surgical, LLC
BR900-7195
In Commercial Distribution

  • 00840183527136 ()
BR900-7195

  • ENT surgical microscope
Closed Wound Facial Drains (Two), Flat, Silicone, With Bifurcated Connector, With ClotStop®
AXIOM MEDICAL, INCORPORATED
412AT
In Commercial Distribution

  • M665412AT3 ()
  • M665412AT1 ()
  • M665412AT0 ()

  • 4 mm


  • Closed-wound drain, non-bioabsorbable
Sump Drain, Three Lumens, Silicone, Small Eye, With Suture Ring, With ClotStop®
AXIOM MEDICAL, INCORPORATED
111197ATSR
In Commercial Distribution

  • M665111197ATSR3 ()
  • M665111197ATSR1 ()
  • M665111197ATSR0 ()

  • Lumen/Inner Diameter: 8.5 Millimeter
  • Length: 14 Inch


  • Sump drain
Sump Drain, Three Lumens, Silicone, Small Eye, With Suture Ring, With ClotStop®
AXIOM MEDICAL, INCORPORATED
111196ATSR
In Commercial Distribution

  • M665111196ATSR3 ()
  • M665111196ATSR1 ()
  • M665111196ATSR0 ()

  • Length: 20 Inch
  • Lumen/Inner Diameter: 8.5 Millimeter


  • Sump drain
Sump Drain, Two Lumens, Silicone, Large Eye, With Suture Ring, With ClotStop®
AXIOM MEDICAL, INCORPORATED
111178ATSR
In Commercial Distribution

  • M665111178ATSR3 ()
  • M665111178ATSR1 ()
  • M665111178ATSR0 ()

  • Lumen/Inner Diameter: 6.5 Millimeter
  • Length: 18 Inch


  • Sump drain
Sump Drain, Two Lumens, Silicone, Small Eye, With Suture Ring, With ClotStop®
AXIOM MEDICAL, INCORPORATED
111177ATSR
In Commercial Distribution

  • M665111177ATSR3 ()
  • M665111177ATSR1 ()
  • M665111177ATSR0 ()

  • Lumen/Inner Diameter: 6.5 Millimeter
  • Length: 12 Inch


  • Sump drain
AUSTRALIAN PLUG, NO WALL MOUNT WITH HAND CONTROL WITH BATTERIES, NO TROLLEY, JOERNS
Amico Mobility Solutions Corporation
GO-LIFT-PTB-450
In Commercial Distribution

  • 00840722000601 ()
NS-GO-LIFT-PORT-450-WR-KIT-AUS-JH

  • Overhead track patient lifting/transfer system
Kellan Capsulorhexis Forceps, with Arruga Style Tips, Round Knurled Handle with Guide Pin
Avalign Technologies, Inc.
92-F2511
In Commercial Distribution

  • 00190776373023 ()


  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Storz Style Deflecting Sheath with Telescope guiding tube for use with Universal Bronchoscopes
Avalign Technologies, Inc.
72-3110357E
In Commercial Distribution

  • 00190776301095 ()


  • Endoscope sheath, reusable
EPSTEIN ABDOMINAL RETRACTOR; 24CM X 60MM WIDE BLADE, WITH TEETH, WITH SILICONE HANDLE
BLACK & BLACK SURGICAL, INC.
B61147
In Commercial Distribution

  • 00840329830038 ()
B61147

  • Hand-held surgical retractor, reusable
8.0Fr, 90cm silicone feeding tube with orange radiopaque stripe with luer lock connection
NEODEVICES INC
FTL8.0S-LL
In Commercial Distribution

  • 10816340027402 ()
  • 10816340020410 ()


  • Nasogastric feeding tube
8.0Fr, 60cm silicone feeding tube with orange radiopaque stripe with luer lock connection
NEODEVICES INC
FTM8.0S-LL
In Commercial Distribution

  • 10816340027396 ()
  • 10816340020403 ()


  • Nasogastric feeding tube
8.0Fr, 40cm silicone feeding tube with orange radiopaque stripe with luer lock connection
NEODEVICES INC
FTS8.0S-LL
In Commercial Distribution

  • 10816340027389 ()
  • 10816340020397 ()


  • Nasogastric feeding tube
6.5Fr, 90cm silicone feeding tube with orange radiopaque stripe with luer lock connection
NEODEVICES INC
FTL6.5S-LL
In Commercial Distribution

  • 10816340027372 ()
  • 10816340020380 ()


  • Nasogastric feeding tube
6.5Fr, 60cm silicone feeding tube with orange radiopaque stripe with luer lock connection
NEODEVICES INC
FTM6.5S-LL
In Commercial Distribution

  • 10816340027365 ()
  • 10816340020373 ()


  • Nasogastric feeding tube
6.5Fr. 40cm silicone feeding tube with orange radiopaque stripe with luer lock connection
NEODEVICES INC
FTS6.5S-LL
In Commercial Distribution

  • 10816340027358 ()
  • 10816340020366 ()


  • Nasogastric feeding tube
5.0Fr, 90cm silicone feeding tube with orange radiopaque stripe with luer lock connection
NEODEVICES INC
FTL5.0S-LL
In Commercial Distribution

  • 10816340027341 ()
  • 10816340020359 ()


  • Nasogastric feeding tube
5.0Fr, 60cm silicone feeding tube with orange radiopaque stripe with luer lock connection
NEODEVICES INC
FTM5.0S-LL
In Commercial Distribution

  • 10816340027334 ()
  • 10816340020342 ()


  • Nasogastric feeding tube
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