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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Integra® Miltex® Botvin Iris Forceps 2-7/8", Cross-Serrated, 0.5mm wide at Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
18-829
In Commercial Distribution

  • H834188290 ()
  • 10381780418108 ()

  • 2-7/8"
  • Width: 0.5 Millimeter
18-829

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Lasik Flap & Track Forceps Curved On Side Of Handle, With Holes At Tips, Stainless
Surgical Direct, Inc.
S34708.100
In Commercial Distribution

  • B382S347081000 ()
S34708.100

  • Lacrimal procedural cannula
Prism, Viewing, fits Flanged Macintosh Blades, Size 4, 30° Refraction at Tip, Acrylic/Stainless
ANESTHESIA ASSOCIATES, INC.
00-349-4
In Commercial Distribution

  • B0050034940 ()
00-349-4

  • Rigid intubation laryngoscope, reusable
Prism, Viewing, fits Flanged Macintosh Blades, Size 3, 30° Refraction at Tip, Acrylic/Stainless
ANESTHESIA ASSOCIATES, INC.
00-349-3
In Commercial Distribution

  • B0050034930 ()
00-349-3

  • Rigid intubation laryngoscope, reusable
Prism, Viewing, fits Flanged Macintosh Blades, Size 2, 30° Refraction at Tip, Acrylic/Stainless
ANESTHESIA ASSOCIATES, INC.
00-349-2
In Commercial Distribution

  • B0050034920 ()
00-349-2

  • Rigid intubation laryngoscope, reusable
5 1/2 Cooley Pediatric Satinsky Clamp, Delicate Clamp, Calibrated Jaws at 5.0mm Intervals
Surgical Direct, Inc.
SD918546016
In Commercial Distribution

  • B382SD9185460160 ()
SD918546016

  • Dressing/utility forceps, scissors-like, reusable
9.6F PLASTIC Pro-Fuse® CT PORT W/ATTACHABLECT PORT W/AT SILICONE CATHETERSILICONE CATHET
Medical Components, Inc.
MRPP96AFS
In Commercial Distribution

  • 50884908147488 ()
  • 00884908147483 ()
MRPP96AFS

  • Vascular port/catheter
Knife Handle, Universal Ring Handle, Camlock To Hold Knives/Probe/Elevators At Any Angle
Med Saver, Inc.
61-7999PIL
In Commercial Distribution

  • 00194613088552 ()


  • Bone lever/elevator, reusable
Chandler Elevator, Blunt, 17mm Width At Tip, 25mm Maximum Width, Overall Length 9" (229mm)
Med Saver, Inc.
D6254
In Commercial Distribution

  • 00194613060893 ()


  • Bone lever/elevator, reusable
Integra® Miltex® Blumenthal Oral Surgery Rongeur, 5-3/4", Jaws at 90° Angle
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
22-482
In Commercial Distribution

  • H834224820 ()
  • 10381780424666 ()

  • Angle: 90 degree
  • 5-3/4"
22-482

  • Dental rongeur
Liquid Urine Control Dipstick - Negative/Positive. Contains 2 vials Negative and 2 vials Positive. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C.
ALTA DIAGNOSTICS INC
303-12
In Commercial Distribution

  • 30858512007052 ()

  • Total Volume: 30 Milliliter
303-12

  • Multiple urine analyte IVD, control
No Description
R82 A/S
Crocodile, Size 3 AT
In Commercial Distribution

  • 05715393022014 ()
86803AT-ATS

  • Handgrip disability-assistive walker, non-powered, foldable
No Description
R82 A/S
Crocodile, Size 2 AT
In Commercial Distribution

  • 05715393021987 ()
86802AT-ATS

  • Handgrip disability-assistive walker, non-powered, foldable
No Description
R82 A/S
Crocodile, Size 1 AT
In Commercial Distribution

  • 05715393021970 ()
86801AT-ATS

  • Handgrip disability-assistive walker, non-powered, foldable
No Description
R82 A/S
Crocodile, Size 3 AT
In Commercial Distribution

  • 05715393021963 ()
86803AT

  • Handgrip disability-assistive walker, non-powered, foldable
No Description
R82 A/S
Crocodile, Size 2 AT
In Commercial Distribution

  • 05715393021956 ()
86802AT

  • Handgrip disability-assistive walker, non-powered, foldable
No Description
R82 A/S
Crocodile, Size 1 AT
In Commercial Distribution

  • 05715393021949 ()
86801AT

  • Handgrip disability-assistive walker, non-powered, foldable
The Proteus XR/f AT Radiographic Systems with (or without) Digital Detector are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
Proteus XR/f AT
In Commercial Distribution

  • 08436046002319 ()


  • Stationary basic diagnostic x-ray system, digital
This Analog or Digital Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
RAD SYSTEM NOVA AT
In Commercial Distribution

  • 08436046002135 ()


  • Stationary basic diagnostic x-ray system, digital
  • Stationary basic diagnostic x-ray system, analogue
No Description
MORIA SA
DSAEK Spatula at 90°
In Commercial Distribution

  • 03700483606559 ()
19083/B

  • General-purpose surgical spatula
No Description
MORIA SA
DSAEK Spatula at 45°
In Commercial Distribution

  • 03700483606542 ()
19083/A

  • General-purpose surgical spatula
No Description
MORIA SA
DSAEK Spatula at 90°
In Commercial Distribution

  • 03700483606535 ()
19077/B

  • General-purpose surgical spatula
No Description
MORIA SA
DSAEK Spatula at 45°
In Commercial Distribution

  • 03700483606528 ()
19077/A

  • General-purpose surgical spatula
A 1-way 60 drops with 60" tube Adset connected to a 3cc transducer. The Safedraw is assembled with a 5cc restricted syringe stops at 2cc, with a 12" Pressure Tubing from the patient and a 48" Pressure tubing to the syringe. It also includes a separately packed 2x male protective caps and a Label Set.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
682142
In Commercial Distribution

  • 50886333621427 ()
  • 00886333621422 ()

  • 3cc transducer, 60 drops Adset and 5cc syringe stops at 2cc
682142

  • Invasive-pressure external transducer, single-use
2-Ply Front/Sleeves Aqua Compel MLR and White ComPel MLR with Negastat, 1-Ply Aqua MLR Comfort Panel Backs, Snap Closures at Neck, Tie Closures at Waist, Circumferentially Offset Sleeves, Overcast Safety Stitch Body
STANDARD TEXTILE CO., INC.
75647454
In Commercial Distribution

  • 00634916788358 ()


  • Surgical gown, reusable
Terragene® Bionova© Reader Incubators (Mini-Bio) incubate at 60 °C and 37 °C and read the Terragene® Bionova© SCBI for fluorescent results at the times prescribed in the User Manuals.
Plasmapp Co.,Ltd.
Mini-bio
In Commercial Distribution

  • 08800066500221 ()


  • Biological sterilization indicator reader
Proov PdG, Progesterone Metabolite Test. The only FDA-Cleared Test to Confirm Successful Ovulation at Home.
Mfb Fertility, Inc.
Confirm
In Commercial Distribution

  • 00860002790817 ()


  • Natural conception assistance kit
microTargeting Single Insertion Tube with Stylet, Sterile, at target, for use with Nexframe and Nexdrive
FHC, INC.
66-IT-DB12P-00327
In Commercial Distribution

  • 10873263003272 ()
  • 00873263003275 ()

  • Length: 211.6 Millimeter
  • Lumen/Inner Diameter: 1.6 Millimeter
  • Outer Diameter: 1.83 Millimeter
66-IT-DB12P

  • Intracerebral cannula, implantable
VERIFY Dual Temperature 28 well incubator allows incubation at two different temperatures in one incubator
STERIS CORPORATION
Incubator
In Commercial Distribution

  • 00724995023911 ()
S3080

  • Test tube heater
Tweezers with the characteristic head of the R-101 packing instrument are incorporated at the tip.
PASCAL COMPANY, INC.
26210
In Commercial Distribution

  • 00310866002484 ()
26210

  • Gingival retraction cord packing tool
MENISCUS CLAMP WITH CURVED SHANK, 1 X 2 TEETH AT TIP OF JAWS, STAINLESS STEEL
ELMED INCORPORATED
23-5274OS
In Commercial Distribution

  • 00198506057007 ()
23-5274OS

  • Arthroscopic surgical procedure kit, non-medicated, reusable
Osteotome, angled, convex, 4.5 mm < 5.0 mm Depth marks at: 8 - 10 - 13 - 15 - 16mm
A. TITAN INSTRUMENTS, INC.
321.06
In Commercial Distribution

  • 00841685101107 ()


  • Dental osteotome
Osteotome, straight, convex, 4.0 mm < 4.5 mm Depth marks at: 8 - 10 - 13 - 15 - 16mm
A. TITAN INSTRUMENTS, INC.
320.05
In Commercial Distribution

  • 00841685101039 ()


  • Dental osteotome
Osteotome, offset, concave, 4.0 mm < 4.5 mm Depth marks at: 8 - 10 - 13 - 15 - 16mm
A. TITAN INSTRUMENTS, INC.
311.05
In Commercial Distribution

  • 00841685100971 ()


  • Dental osteotome
Osteotome, offset, concave, 3.5 mm < 4.0 mm Depth marks at: 8 - 10 - 13 - 15 - 16mm
A. TITAN INSTRUMENTS, INC.
311.04
In Commercial Distribution

  • 00841685100964 ()


  • Dental osteotome
Exchangeable suction-Irrigation tube M8 x 1, Ø 10mm, markings and 4 holes at distal end
Pajunk GmbH Medizintechnologie
1298-00-10
Not in Commercial Distribution

  • 04048223006610 ()
1298-00-10

  • Laparoscopic access cannula, reusable
Exchangeable suction-Irrigation tube M8 x 1, Ø 5mm, markings and 4 holes at distal end
Pajunk GmbH Medizintechnologie
1298-00-05
Not in Commercial Distribution

  • 04048223006597 ()
1298-00-05

  • Laparoscopic access cannula, reusable
Exchangeable suction-Irrigation tube M8 x 1, Ø 3mm, markings and 4 holes at distal end
Pajunk GmbH Medizintechnologie
1298-00-03
Not in Commercial Distribution

  • 04048223006573 ()
1298-00-03

  • Laparoscopic access cannula, reusable
AUSTIN Measuring probe (caliper)determin length of stapes prosthesis, 6 1/4" markings at 4.5mm
RZ-Medizintechnik GmbH
410-142-145
In Commercial Distribution

  • 04049197471510 ()
410-142-145

  • General surgery wound probe/packer
AUSTIN Measuring probe (caliper) determe length of stapes prosthesis, 6 1/4" markings at 3.5mm
RZ-Medizintechnik GmbH
410-142-135
In Commercial Distribution

  • 04049197471497 ()
410-142-135

  • General surgery wound probe/packer
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