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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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
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
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
Offset Boxed Osteotome, Surgical Grade Autoclavable Stainless Steel -- (Additional Specs on file at Elmed)
ELMED INCORPORATED
23-7806-01001
In Commercial Distribution

  • 00842180163478 ()
23-7806-01001

  • Orthopaedic osteotome
Modified Blunt Hohmann Retractor, Standard, Blade Width at End: 11mm, Overall Length: 10.75" (27,3cm)
ELMED INCORPORATED
23-4550
In Commercial Distribution

  • 00842180169722 ()
23-4550

  • Hand-held surgical retractor, reusable
Osteotome, angled, convex, 3.5 mm <4.0 mmDepth marks at: 8 - 10 - 13 - 15 - 16mm
A. TITAN INSTRUMENTS, INC.
321.04
In Commercial Distribution

  • 00841685101084 ()


  • Dental osteotome
Osteotome, offset, concave, 4.5 mm <5.0 mmDepth marks at: 8 - 10 - 13 - 15 - 16mm
A. TITAN INSTRUMENTS, INC.
311.06
In Commercial Distribution

  • 00841685100988 ()


  • Dental osteotome
Osteotome, straight, concave, 4.5 mm < 5.0 mmDepth marks at: 8 - 10 - 13 - 15 - 16mm
A. TITAN INSTRUMENTS, INC.
310.06
In Commercial Distribution

  • 00841685100926 ()


  • Dental osteotome
Osteotome, straight, concave, 4.0 mm <4.5 mmDepth marks at: 8 - 10 - 13 - 15 - 16mm
A. TITAN INSTRUMENTS, INC.
310.05
In Commercial Distribution

  • 00841685100919 ()


  • Dental osteotome
Osteotome, straight, concave, 3.5 mm < 4.0 mmDepth marks at: 8 - 10 - 13 - 15 - 16mm
A. TITAN INSTRUMENTS, INC.
310.04
In Commercial Distribution

  • 00841685100902 ()


  • Dental osteotome
anthony suction tube, 5 7/8" (14.9 cm), large: 3.0 mm lumen at tip
NOVO SURGICAL, INC.
E7221-77
In Commercial Distribution

  • 00842331130670 ()
E7221-77

  • Airway suction catheter
TEBBETTS AUFRICHT RETRACTOR, WITH STABILIZATION TEETH AT THE TIP, OVERALL LENGTH 4-3/4" (12CM)
ELMED INCORPORATED
ST151079
In Commercial Distribution

  • 00842180191921 ()
ST151079

  • Hand-held surgical retractor, reusable
TEBBETTS AUFRICHT RETRACTOR, WITH STABILIZATION TEETH AT THE TIP, OVERALL LENGTH 4-3/4" (12CM)
ELMED INCORPORATED
15-1079
In Commercial Distribution

  • 00842180183100 ()
15-1079

  • Hand-held surgical retractor, reusable
Offset Boxed Osteotome, Surgical Grade Autoclavable Stainless Steel -- (Additional Specs on file at Elmed)
ELMED INCORPORATED
ST23780601001
In Commercial Distribution

  • 00842180197404 ()
ST23780601001

  • Orthopaedic osteotome
Modified Blunt Hohmann Retractor, Standard, Blade Width at End: 11mm, Overall Length: 10.75" (27,3cm)
ELMED INCORPORATED
ST234550
In Commercial Distribution

  • 00842180196773 ()
ST234550

  • Hand-held surgical retractor, reusable
HATCHET TGF 15L R-DOWN CUT, IN/OUT SHAPE, AT 2 O'CLOCK, for Duggan Institute
Power Dental U.S.A. Inc.
2321
In Commercial Distribution

  • D9432321 ()
2321

  • Dressing/utility forceps, scissors-like, reusable
  • Periodontal hoe
HATCHET TGF 13L L-DOWN CUT, IN/OUT SHAPE, AT 2 O'CLOCK, for Duggan Institute
Power Dental U.S.A. Inc.
2320
In Commercial Distribution

  • D9432320 ()
2320

  • Dressing/utility forceps, scissors-like, reusable
  • Periodontal hoe
Software to identify heart failure patients who may be at risk of having wtATTR-CM
PFIZER INC.
CI4054279
In Commercial Distribution

  • 05415062388310 ()


  • Cardiovascular interpretive screening software
Infrared phototherapy device emitting up to 10 W at 810/980 nm, 7" display
LITECURE LLC
LTC-1001-L-B6
In Commercial Distribution

  • 00854103007295 ()


  • Musculoskeletal/physical therapy laser, professional
Infrared phototherapy device emitting up to 8W at 810/980nm, battery option, 10" display
LITECURE LLC
LTC-1510-SOLA
In Commercial Distribution

  • 00854103007066 ()


  • Musculoskeletal/physical therapy laser, professional
VMS Left Posterior Aiming Device (Re-Use): Used to score the femoral neck at 45°.
ELITE SURGICAL SUPPLIES (PTY) LTD
VMSAD14
In Commercial Distribution

  • 06009712290413 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
VMS Right Posterior Aiming Device (Re-Use): Used to score the femoral neck at 45°.
ELITE SURGICAL SUPPLIES (PTY) LTD
VMSAD13
In Commercial Distribution

  • 06009712290406 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
VMS Left Anterior Aiming Device (Re-Use): Used to score the femoral neck at 45°
ELITE SURGICAL SUPPLIES (PTY) LTD
VMSAD12
In Commercial Distribution

  • 06009712290390 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
VMS Right Anterior Aiming Device (Re-Use): Used to score the femoral neck at 45°.
ELITE SURGICAL SUPPLIES (PTY) LTD
VMSAD11
In Commercial Distribution

  • 06009712290383 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Bone molder - used to compress bone in between dental Implants at time of placement
Suncoast Dental, Inc
Bone Molder - Straight
In Commercial Distribution

  • 00083208130120 ()
Bone Molder - Straight

  • Osteotomy compression/distraction instrument
5mm 32cm Strong Forceps, Fenestrated, Serrated, Oval-Shaped Jaw that Converge at Distal End, Double
Surgical Direct, Inc.
SD88333.100
In Commercial Distribution

  • B382SD883331000 ()
SD88333.100

  • Laparoscopic tissue manipulation forceps/working-channel
Integra® Miltex® McCullough Utility Forceps, 4-1/8", Smooth, 1.25mm Wide at Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
18-962
In Commercial Distribution

  • H834189620 ()
  • 10381780418528 ()

  • 4-1/8"
  • Width: 1.25 Millimeter
18-962

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Integra® Miltex® Bishop-Harmon Dressing Forceps, 3-3/8", Cross-Serrated, 0.5mm Wide at Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
18-866
In Commercial Distribution

  • H834188660 ()
  • 10381780418238 ()

  • Width: 0.5 Millimeter
  • 3-3/8"
18-866

  • Dressing/utility forceps, tweezers-like, reusable
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
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
Integra® Miltex® Mini-Blumenthal Oral Surgery Rongeur 5-1/4", Jaws at 25° Angle
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
22D-422
In Commercial Distribution

  • H83422D4220 ()
  • 10381780424833 ()
22D-422

  • Dental rongeur
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
Integra® Jarit® Anthony Suction Tube, 5-7/8", Large, 3mm Lumen At Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
385062
In Commercial Distribution

  • M2743850621 ()
  • 10381780190080 ()
385-062

  • Surgical/emergency suction cannula, non-illuminating, reusable
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