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, Large, for use with Laser
Surgical Direct, Inc.
SD165113
In Commercial Distribution

  • B382SD1651130 ()
SD165113

  • Vaginal speculum, reusable
Collin Vaginal Speculum with Smoke Evacuation Tube, Medium, for use with Laser
Surgical Direct, Inc.
SD165112
In Commercial Distribution

  • B382SD1651120 ()
SD165112

  • Vaginal speculum, reusable
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 32cm Babcock Forceps, with Locking Reinforced, Carbon Fiber Handle, with Flushport.
Surgical Direct, Inc.
SD15418-35
In Commercial Distribution

  • B382SD15418350 ()
SD15418-35

  • Flexible endoscopic tissue manipulation forceps, single-use
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
10mm 45cm Babcock Forceps with Locking, Carbon Fiber, Reinforced, with swing-away Ratchet
Surgical Direct, Inc.
SD15408-64
In Commercial Distribution

  • B382SD1540864 ()
SD15408-64

  • Flexible endoscopic tissue manipulation forceps, single-use
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
5mm 45cm Maryland Dissector with Cross Serrations, Rotating, with Non-Locking Reinforced, SimpleCLIC
Surgical Direct, Inc.
SD13188-88
In Commercial Distribution

  • B382SD13188880 ()
SD13188-88

  • Flexible endoscopic tissue manipulation forceps, single-use
Integra® Miltex® PESSARY RING WITH KNOB SIZE 7 WITH SUPPORT
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
30-RKS7
In Commercial Distribution

  • H83430RKS71 ()
  • 10381780171645 ()

  • Size 7 (3.50" OD)
30-RKS7

  • Pelvic-organ-supporting pessary
Integra® Miltex® PESSARY RING WITH KNOB SIZE 6 WITH SUPPORT
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
30-RKS6
In Commercial Distribution

  • H83430RKS61 ()
  • 10381780171638 ()

  • Size 6 (3.25" OD)
30-RKS6

  • Pelvic-organ-supporting pessary
Integra® Miltex® PESSARY RING WITH KNOB SIZE 5 WITH SUPPORT
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
30-RKS5
In Commercial Distribution

  • H83430RKS51 ()
  • 10381780171621 ()

  • Size 5 (3.00" OD)
30-RKS5

  • Pelvic-organ-supporting pessary
Integra® Miltex® PESSARY RING WITH KNOB SIZE 4 WITH SUPPORT
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
30-RKS4
In Commercial Distribution

  • H83430RKS41 ()
  • 10381780171614 ()

  • Size 4 (2.75" OD)
30-RKS4

  • Pelvic-organ-supporting pessary
Integra® Miltex® PESSARY RING WITH KNOB SIZE 2 WITH SUPPORT
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
30-RKS2
In Commercial Distribution

  • H83430RKS21 ()
  • 10381780171591 ()

  • Size 2 (2.25" OD)
30-RKS2

  • Pelvic-organ-supporting pessary
Integra® Miltex® PESSARY RING WITH KNOB SIZE 1 WITH SUPPORT
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
30-RKS1
In Commercial Distribution

  • H83430RKS11 ()
  • 10381780171584 ()

  • Size 1 (2.00" OD)
30-RKS1

  • Pelvic-organ-supporting pessary
5mm 32cm Maryland Dissector with Cross Serrations, Rotating, with Non-Locking Reinforced, SimpleCLIC
Surgical Direct, Inc.
SD13188-77
In Commercial Distribution

  • B382SD13188770 ()
SD13188-77

  • Flexible endoscopic tissue manipulation forceps, single-use
32cm Atraumatic Grasper with Scoop, Double Action, Rotating, with Non-Locking Reinforced, SimpleCLIC
Surgical Direct, Inc.
SD13108-77
In Commercial Distribution

  • B382SD13108770 ()
SD13108-77

  • Flexible endoscopic tissue manipulation forceps, single-use
5.5mm, Hasson Cannula With Trumpet Valve With Suture Ties On Cannula Body
Surgical Direct, Inc.
SD106659
In Commercial Distribution

  • B382SD1066590 ()
SD106659

  • Laparoscopic access cannula, reusable
Integra® Miltex® PESSARY RING WITH KNOB SIZE 3 WITH SUPPORT
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
30-RKS3
In Commercial Distribution

  • H83430RKS31 ()
  • 10381780171607 ()

  • Size 3 (2.50" OD)
30-RKS3

  • Pelvic-organ-supporting pessary
Integra® Miltex® PESSARY RING WITH KNOB SIZE 0 WITH SUPPORT
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
30-RKS0
In Commercial Distribution

  • H83430RKS01 ()
  • 10381780171577 ()

  • Size 0 (1.75" OD)
30-RKS0

  • Pelvic-organ-supporting pessary
Gerald Straight Bipolar Forcep 7" (177.8mm) With A With A 1.0mm Tip
TITAN MANUFACTURING INC
162310233060101
In Commercial Distribution

  • 00817914020709 ()

  • Length: 7 Inch


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Cushing Straight Bipolar Forcep 7" (177.8mm) With A With A 1.5mm Tip
TITAN MANUFACTURING INC
162110233080101
In Commercial Distribution

  • 00817914020471 ()

  • Length: 7 Inch


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Cushing Straight Bipolar Forcep 6" (152.4mm) With A With A 0.7mm Tip
TITAN MANUFACTURING INC
162110225040101
In Commercial Distribution

  • 00817914020464 ()

  • Length: 6 Inch


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Floor-Mounted Tubestand longitudinal tube travel 2m. with advanced control with Digital SID
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR100
In Commercial Distribution

  • 00817100020063 ()


  • Stationary basic diagnostic x-ray system, digital
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 #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 #0; 1 3/4" (44mm)
Coopersurgical, Inc.
MXPRSK00
In Commercial Distribution

  • 00888937008807 ()


  • Pelvic-organ-supporting pessary
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
Smart Outlet and Economy Cordless Monitor with bed pad with remote reset
Smart Caregiver Corporation
433SBS1EC-SYS
In Commercial Distribution

  • 00812293013762 ()


  • Bed/chair occupant movement pressure/vibration sensor
Smart Outlet with CordLess bed pad with hallway alert and remote reset
Smart Caregiver Corporation
RP-433SBS1EC-SYS
In Commercial Distribution

  • 00812293013151 ()


  • Bed/chair occupant movement pressure/vibration sensor
Smart Outlet with CordLess chair pad with hallway alert and remote reset
Smart Caregiver Corporation
RP-433SC1EC-SYS
In Commercial Distribution

  • 00812293013144 ()


  • Bed/chair occupant movement pressure/vibration sensor
Smart Outlet and Economy Cordless Monitor with bed pad with remote reset
Smart Caregiver Corporation
433SBR1EC-SYS
In Commercial Distribution

  • 00812293011966 ()


  • Bed/chair occupant movement pressure/vibration sensor
Probe Extension with Ball Tip, 12 cm for use with Checkpoint Stimulators
Checkpoint Surgical, Inc.
9505
In Commercial Distribution

  • B13095051 ()
  • B13095050 ()
  • B13095052 ()
  • B13095053 ()
9505

  • Nerve-locating system
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
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