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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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S-ROM Modular Hip System SPA Proximal Sleeve POROUS COATED 14 B FITS: 14 x 09 OR 14 x 08 STEM Cone: B
DEPUY ORTHOPAEDICS, INC.
53-5342
In Commercial Distribution

  • 10603295172451 ()
535342

  • Sleeve femoral/tibial extension, coated
S-ROM Modular Hip System SPA Proximal Sleeve POROUS COATED 12 B FITS: 12 x 06 OR 12 x 07 STEM Cone: B
DEPUY ORTHOPAEDICS, INC.
53-5332
Not in Commercial Distribution

  • 10603295172444 ()
535332

  • Sleeve femoral/tibial extension, coated
LAP-BAND® Access Port Needle 3.5 inch Pouch
ReShape Lifesciences Inc.
B-20301-10
In Commercial Distribution

  • 10850007764330 ()
  • 10811955020411 ()
  • 00850007764333 ()
B-20301-10

  • Subcutaneous infusion/injection port needle
LAP-BAND® Access Port Needle 2 inch Pouch
ReShape Lifesciences Inc.
B-20302-10
In Commercial Distribution

  • 10850007764323 ()
  • 10811955020428 ()
  • 00850007764326 ()
B-20302-10

  • Subcutaneous infusion/injection port needle
The Carl Zeiss Meditec MEL 90 Excimer Laser System is designed for refractive surgery based on the ablation of corneal tissue achieved with a short pulse excimer laser having a wavelength of 193 nanometers. The laser head emits 4 to 7 nanosecond pulses (FWHM nominal pulse duration) with a repetition rate of 500 Hz. The MEL 90 Excimer Laser is a spot-scanning laser that utilizes a Gaussian beam with a 0.7 mm spot diameter. Indications for Use: The MEL 90 is indicated for use in primary Laser-Assisted in situ Keratomileusis (LASIK) treatments for the reduction or elimination of: • Myopia less in magnitude than -10.00 D sphere (in minus-cylinder notation), with and without cylinder up to -4.00 D, when MRSE is less in magnitude than -10.00 D; • Hyperopia up to +4.00 D sphere (in plus-cylinder notation), with and without cylinder up to +3.00 D, when MRSE is up to +5.00 D; and • Mixed astigmatism with cylinder from >1.00 D up to 4.00 D; in patients who are 18 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change in MRSE within +/- 0.50 D.
Carl Zeiss Meditec AG
1900-109
In Commercial Distribution

  • 04049471095074 ()

  • Weight: 295 Kilogram
  • x W x H: 1.63 m x 0.73 m x 1.48 m to 1.70 m


  • Ophthalmic excimer laser system
Cochlear Nucleus CI24RE Series Non-Sterile Silicone Implant Template x 5
COCHLEAR LIMITED
Z33020
In Commercial Distribution

  • 09321502002271 ()
  • 09321502031530 ()
Z33020

  • Surgical implant template, reusable
ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, 1/2IN X 1IN, 7MM THICK
Integra Lifesciences Corporation
1690-ZZ
In Commercial Distribution

  • 10381780000198 ()
  • 00381780000191 ()
  • M2691690ZZ0 ()

  • 1.27 cm x 2.54 cm x 7.0 mm
  • 1/2 in x 1in x 7.0 mm
1690-ZZ

  • Collagen haemostatic agent, non-antimicrobial
Algovita® spinal cord stimulation system stimulator (2 x 12)
Greatbatch Ltd
2412-USA
In Commercial Distribution

  • 00821329580017 ()
2412

  • Analgesic spinal cord electrical stimulation system
P.F.C. SIGMA CEMENTED FEMORAL STEM 15mm x 130mm 7 DEGREE
DEPUY (IRELAND)
96-1732
In Commercial Distribution

  • 10603295240082 ()
961732

  • Knee femur stem prosthesis
P.F.C. SIGMA CEMENTED FEMORAL STEM 13mm x 130mm 7 DEGREE
DEPUY (IRELAND)
96-1731
In Commercial Distribution

  • 10603295240075 ()
961731

  • Knee femur stem prosthesis
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