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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Collin Vaginal Speculum with Smoke Evacuation Tube, Small, for use with Laser
Surgical Direct, Inc.
SD165111
In Commercial Distribution

  • B382SD1651110 ()
SD165111

  • Vaginal speculum, reusable
Graves Vaginal Speculum, Medium, with Smoke Evacuation Tube, For Use with Laser
Surgical Direct, Inc.
SD165102
In Commercial Distribution

  • B382SD1651020 ()
SD165102

  • Vaginal speculum, reusable
5mm 36cm Babcock Forceps, with Locking Reinforced, Carbon Fiber Handle, with Flushport.
Surgical Direct, Inc.
SD15418-31
In Commercial Distribution

  • B382SD15418310 ()
SD15418-31

  • Flexible endoscopic tissue manipulation forceps, single-use
Ring with support with knob folding Pessary #12; 4 3/4" (121mm)
Coopersurgical, Inc.
MXPRSK12
In Commercial Distribution

  • 00888937008920 ()


  • Pelvic-organ-supporting pessary
Ring with support with knob folding Pessary #11; 4 1/2" (114mm)
Coopersurgical, Inc.
MXPRSK11
In Commercial Distribution

  • 00888937008913 ()


  • Pelvic-organ-supporting pessary
Ring with support with knob folding Pessary #10; 4 1/4" (108mm)
Coopersurgical, Inc.
MXPRSK10
In Commercial Distribution

  • 00888937008906 ()


  • Pelvic-organ-supporting pessary
Ring with support with knob folding Pessary #8; 3 3/4" (95mm)
Coopersurgical, Inc.
MXPRSK08
In Commercial Distribution

  • 00888937008883 ()


  • Pelvic-organ-supporting pessary
Ring with support with knob folding Pessary #7; 3 1/2" (89mm)
Coopersurgical, Inc.
MXPRSK07
In Commercial Distribution

  • 00888937008876 ()


  • Pelvic-organ-supporting pessary
Ring with support with knob folding Pessary #6; 3 1/4" (83mm)
Coopersurgical, Inc.
MXPRSK06
In Commercial Distribution

  • 00888937008869 ()


  • Pelvic-organ-supporting pessary
Ring with support with knob folding Pessary #3; 2 1/2" (64mm)
Coopersurgical, Inc.
MXPRSK03
In Commercial Distribution

  • 00888937008838 ()


  • Pelvic-organ-supporting pessary
Ring with support with knob folding Pessary #2; 2 1/4" (57mm)
Coopersurgical, Inc.
MXPRSK02
In Commercial Distribution

  • 00888937008821 ()


  • Pelvic-organ-supporting pessary
Ring with support with knob folding Pessary #0; 1 3/4" (44mm)
Coopersurgical, Inc.
MXPRSK00
In Commercial Distribution

  • 00888937008807 ()


  • Pelvic-organ-supporting pessary
5mm, 35cm Hook Biopsy Punch, With Non-Locking Insulated Handle with HF Post
Surgical Direct, Inc.
SD9884213510
In Commercial Distribution

  • B382SD98842135100 ()
SD9884213510

  • Laparoscopic tissue manipulation forceps/working-channel
OxyArm Plus Clear Adjustable Head Band with Diffuser Arm with 7' tubing
Southmedic Incorporated
OA-PLUS-1125-8
In Commercial Distribution

  • 00620974000075 ()
  • 10620974000072 ()
OA-PLUS-1125-8

  • Vortex oxygen face mask
Light Green O-type 3-Point Head Mask (with nosehole) with 12% perforation, 2.4mm
Klarity Medical Products, LLC
RDLG105-2412C
In Commercial Distribution

  • 00817355022454 ()


  • Patient positioning thermoplastic mould material
TiOS Scan Body with Screw Compatible with Biomet 3i Certain Internal 3.4
Biodenta Swiss AG
CAD-TSBB3I34S
In Commercial Distribution

  • 07640169736704 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
TiOS Scan Body with Screw Compatible with Astra Tech OsseoSpeed 4.5/5.0
Biodenta Swiss AG
CAD-TSBAOS4550S
In Commercial Distribution

  • 07640169736698 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
TiOS Scan Body with Screw Compatible with Astra Tech OsseoSpeed 3.5/4.0
Biodenta Swiss AG
CAD-TSBAOS3540S
In Commercial Distribution

  • 07640169736681 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
Scan Body with Screw Compatible with Astra Tech OsseoSpeed 3.5/4.0 IOS
Biodenta Swiss AG
CAD-SBATOS3545
In Commercial Distribution

  • 07640169736346 ()
CAD-SBATOS3545

  • Dental implant abutment analog, intraoral-scanning, single-use
Ti Hybrid part with Screw compatible with Osstem (Hiossen) TSIII Regular GH1.5
Biodenta Swiss AG
CAD-THAOTS4515S
In Commercial Distribution

  • 07640169735110 ()
CAD-THAOTS4515S

  • Dental implant suprastructure, permanent, preformed
PreFAB-4 Blank with Screw compatible with Osstem (Hiossen) TSIII Regular Wide D16
Biodenta Swiss AG
CAD-TPOTS45WS
In Commercial Distribution

  • 07640169732072 ()
CAD-TPOTS45WS

  • Dental implant suprastructure, permanent, preformed
PreFAB-4 Blank with Screw compatible with Osstem (Hiossen) TSIII Regular Narrow D9.9
Biodenta Swiss AG
CAD-TPOTS45NS
In Commercial Distribution

  • 07640169732065 ()
CAD-TPOTS45NS

  • Dental implant suprastructure, permanent, preformed
PreFAB-4 Blank with Screw compatible with Osstem (Hiossen) TSIII Mini Narrow D9.9
Biodenta Swiss AG
CAD-TPOTS35NS
In Commercial Distribution

  • 07640169732058 ()
CAD-TPOTS35NS

  • Dental implant suprastructure, permanent, preformed
PreFAB-4 Blank with Screw compatible with Straumann Bone Level RC Wide D16
Biodenta Swiss AG
CAD-TPSBLRCWS
In Commercial Distribution

  • 07640169731945 ()
CAD-TPSBLRCWS

  • Dental implant suprastructure, permanent, preformed
PreFAB-4 Blank with Screw compatible with Straumann Bone Level RC Narrow D9.9
Biodenta Swiss AG
CAD-TPSBLRCNS
In Commercial Distribution

  • 07640169731938 ()
CAD-TPSBLRCNS

  • Dental implant suprastructure, permanent, preformed
PreFAB-4 Blank with Screw compatible with Straumann Bone Level NC Wide D16
Biodenta Swiss AG
CAD-TPSBLNCWS
In Commercial Distribution

  • 07640169731921 ()
CAD-TPSBLNCWS

  • Dental implant suprastructure, permanent, preformed
PreFAB-4 Blank with Screw compatible with Straumann Bone Level NC Narrow D9.9
Biodenta Swiss AG
CAD-TPSBLNCNS
In Commercial Distribution

  • 07640169731914 ()
CAD-TPSBLNCNS

  • Dental implant suprastructure, permanent, preformed
15 FR Round Fluted, Full with Trocar Kit with 100 cc Evacuator
TYPENEX MEDICAL LLC
WD0503TK1
In Commercial Distribution

  • 00812269030427 ()
  • 00812269030410 ()


  • Closed-wound drainage kit
ICONIX 2 NEEDLES WITH INTELLIBRAID TECHNOLOGY, 2.3MM ANCHOR WITH 2.0MM XBRAID TT
STRYKER CORPORATION
3910500222
In Commercial Distribution

  • 37613327283465 ()
  • 07613327283464 ()

  • Diameter: 2.3 Millimeter
3910-500-222

  • Tendon/ligament bone anchor, non-bioabsorbable
ICONIX 1 NEEDLES WITH INTELLIBRAID TECHNOLOGY, 1.4MM ANCHOR WITH 1.2MM XBRAID TT
STRYKER CORPORATION
3910500212
In Commercial Distribution

  • 37613327283441 ()
  • 07613327283440 ()

  • Diameter: 1.4 Millimeter
3910-500-212

  • Tendon/ligament bone anchor, non-bioabsorbable
Rechargable streak retinoscope Set,with 489 handle,with DT801 charger,Zipper bag
Zumax Medical Co., LTD
SR24A
In Commercial Distribution

  • 06945095531180 ()


  • Retinoscope, battery-powered
PowerPICC Catheter with Sherlock 3CG TPS Stylet 6F Basic Tray with Microintroducer
Bard Access Systems, Inc.
1386118
In Commercial Distribution

  • 10801741034708 ()
  • 00801741034701 ()

  • Length: 55 Centimeter
  • Catheter Gauge: 6 French
1386118

  • Peripherally-inserted central venous catheter
4F REG MICRO-STICK® INTRODUCER SET WITH NITINOL GUIDEWIRE WITH RADIOPAQUE TIP
Medical Components, Inc.
RMS19421
Not in Commercial Distribution

  • 00884908158199 ()
  • 00884908088632 ()
  • 30884908158190 ()
  • 50884908158194 ()
RMS19421

  • Vascular dilator, single-use
5F REGULAR MICRO-STICK® INTRODUCER SET WITH NITINOL GUIDEWIRE WITH RADIOPAQUE TIP
Medical Components, Inc.
RMS19521
Not in Commercial Distribution

  • 50884908088750 ()
  • 30884908088756 ()
  • 00884908088755 ()


  • Vascular dilator, single-use
5F REGULAR MICRO-STICK® INTRODUCER SET WITH NITINOL GUIDEWIRE WITH RADIOPAQUE TIP
Medical Components, Inc.
AAC19521
Not in Commercial Distribution

  • 30884908088749 ()
  • 00884908088748 ()
  • 50884908088743 ()


  • Vascular dilator, single-use
5F STIFF MICRO-STICK® INTRODUCER SET WITH NITINOL GUIDEWIRE WITH RADIOPAQUE TIP
Medical Components, Inc.
RMS19511
Not in Commercial Distribution

  • 50884908088699 ()
  • 30884908088695 ()
  • 00884908088694 ()


  • Vascular dilator, single-use
5F STIFF MICRO-STICK® INTRODUCER SET WITH NITINOL GUIDEWIRE WITH RADIOPAQUE TIP
Medical Components, Inc.
AAC19511
Not in Commercial Distribution

  • 50884908088682 ()
  • 30884908088688 ()
  • 00884908088687 ()


  • Vascular dilator, single-use
4F REGULAR MICRO-STICK® INTRODUCER SET WITH NITINOL GUIDEWIRE WITH RADIOPAQUE TIP
Medical Components, Inc.
RMS19421
Not in Commercial Distribution

  • 30884908088633 ()
  • 00884908088632 ()
  • 50884908088637 ()


  • Vascular dilator, single-use
4F REGULAR MICRO-STICK® INTRODUCER SET WITH NITINOL GUIDEWIRE WITH RADIOPAQUE TIP
Medical Components, Inc.
AAC19421
Not in Commercial Distribution

  • 50884908088620 ()
  • 00884908088625 ()
  • 30884908088626 ()


  • Vascular dilator, single-use
4F STIFF MICRO-STICK® INTRODUCER SET WITH NITINOL GUIDEWIRE WITH RADIOPAQUE TIP
Medical Components, Inc.
RMS19411
Not in Commercial Distribution

  • 50884908088576 ()
  • 30884908088572 ()
  • 00884908088571 ()


  • Vascular dilator, single-use
4F STIFF MICRO-STICK® INTRODUCER SET WITH NITINOL GUIDEWIRE WITH RADIOPAQUE TIP
Medical Components, Inc.
AAC19411
Not in Commercial Distribution

  • 50884908088569 ()
  • 00884908088564 ()
  • 30884908088565 ()


  • Vascular dilator, single-use
WAM wireless acquisition module with 10 wire IEC lead set with clips
WELCH ALLYN, INC.
901095
In Commercial Distribution

  • 00732094272130 ()
41000-031-53

  • Electrocardiograph, professional, multichannel
AM12 acquisition module with 10 wire IEC lead set with banana plugss
WELCH ALLYN, INC.
901095
In Commercial Distribution

  • 00732094272109 ()
41000-032-51

  • Electrocardiograph, professional, multichannel
Reusable NIBP cuff/with ring/Double Tube/with inflation bag/Adult(25-35cm)
Unimed Medical Supplies, Inc.
U1880HD
In Commercial Distribution

  • 06945664869300 ()


  • Blood pressure cuff, reusable
Reusable NIBP cuff/with ring/Single Tube/with inflation bag/Adult(25-35cm)
Unimed Medical Supplies, Inc.
U1880HS
In Commercial Distribution

  • 06945664869270 ()


  • Blood pressure cuff, reusable
lingual sheath Weldable With hook / with indent( mesial R) 10 pcs/pk
Ortho Pro Dent LLC
CSS-LS-105
In Commercial Distribution

  • 00810152826294 ()


  • Orthodontic metal band
lingual sheath Weldable With hook / with indent (mesial L) 10 pcs/pk
Ortho Pro Dent LLC
CSS-LS-104
In Commercial Distribution

  • 00810152826287 ()


  • Orthodontic metal band
lingual sheath Weldable With hook /with indent (distal R) 10 pcs/pk
Ortho Pro Dent LLC
CSS-LS-103
In Commercial Distribution

  • 00810152826270 ()


  • Orthodontic metal band
lingual sheath Weldable With Hook /with indent( distal L) 10 pcs/pk
Ortho Pro Dent LLC
CSS-LS-102
In Commercial Distribution

  • 00810152826263 ()


  • Orthodontic metal band
VECTORMatic Straight Nose Cone 1:1 with External/Internal Irrigation With Light
Vector R&D, Inc.
VM10L-SG
In Commercial Distribution

  • 00810113691107 ()
VM10L-SG

  • Dental surgical power tool motorized handpiece/set, electric
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