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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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ES-1.1 / 40 Shore black-opaque 8 double cartridges with 48 ml each
pro3dure medical GmbH
Shore 40 / 8 double cartridges of 2 x 24 ml - black opaque
In Commercial Distribution

  • EPRCA0031776 ()
A0031776

  • Earmould, custom-made
ES-1.1 / 40 Shore white-opaque 8 double cartridges with 48 ml each
pro3dure medical GmbH
Shore 40 / 8 double cartridges of 2 x 24 ml - white opaque
In Commercial Distribution

  • EPRCA0031500 ()
A0031500

  • Earmould, custom-made
ES-1.1 / 25 Shore neon-orange opaque 8 double cartridges with 48 ml each
pro3dure medical GmbH
Shore 25 / 8 double cartridges of 2 x 24 ml - neon-orange opaque
In Commercial Distribution

  • EPRCA0031327 ()
A0031327

  • Earmould, custom-made
ES-1.1 / 25 Shore light-blue opaque 8 double cartridges with 48 ml each
pro3dure medical GmbH
Shore 25 / 8 double cartridges of 2 x 24 ml - light-blue opaque
In Commercial Distribution

  • EPRCA0031128 ()
A0031128

  • Earmould, custom-made
ES-1.1 / 25 Shore neon-pink opaque 8 double cartridges with 48 ml each
pro3dure medical GmbH
Shore 25 / 8 double cartridges of 2 x 24 ml - neon-pink opaque
In Commercial Distribution

  • EPRCA0030903 ()
A0030903

  • Earmould, custom-made
ES-1.1 / 25 Shore clear-transparent 8 double cartridges with 48 ml each
pro3dure medical GmbH
Shore 25 / 8 double cartridges of 2 x 24 ml - clear transparent
In Commercial Distribution

  • EPRCA0030800 ()
A0030800

  • Earmould, custom-made
ES-1.1 / 25 Shore neon-yellow opaque 8 double cartridges with 48 ml each
pro3dure medical GmbH
Shore 25 / 8 double cartridges of 2 x 24 ml - neon-yellow opaque
In Commercial Distribution

  • EPRCA0030729 ()
A0030729

  • Earmould, custom-made
The Integra Ti6 Internal Fixation System is comprised of Digital screws used for bone fixation of the hand and foot following trauma or osteotomy. The Digital Screw is a cannulated, threaded bone screw which is offered in a 2.0mm diameter with lengths of 24 to 50mm. The system includes titanium and stainless steel instruments to facilitate the placement of the screws.
Ascension Orthopedics, Inc.
TI6DIGITIMP
Not in Commercial Distribution

  • M268TI6DIGITIMP1 ()
  • 10381780074304 ()
TI6DIGITIMP

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Overall size 24”W x 20.5”D x 64.75”T. 9.73 Cubic ft. storage Chamber I.D. 20”W x 17”D x 49.5”T. Temperature Range: 90-160 F Accuracy +/- 1 degrees F of set point 3 Adjustable shelves Digital control Glass door Audible and visual over-temp alarm Data Logger Mobile Base Electrical: 120V, 7.5 Amp, 50/60 Hz .49kw/hr, 1678 btu/hr
M.A.C. MEDICAL INC.
FHCSWC2460-TL-G-D-MB
In Commercial Distribution

  • B286FHCSWC2460TLGDMB1 ()
FHCSWC2460-TL-G-D-MB

  • Blanket warming cabinet, dry-heat
Overall size 24”W x 20.5”D x 24.5”T. 3.0 Cubic ft. storage Chamber I.D. 20”W x 17"D x 15.25”T Temperature Range: 90-160 F Accuracy +/- 1 degrees F Touch Screen Glass door Audible and visual over-temp alarm. Keyed temperature lock for each chamber Data Logger Foot levelers Electrical: 120V, 3.5 Amp, 50/60 Hz. .45kw/hr, 1537 btu/hr.
M.A.C. MEDICAL INC.
FHCSWC1824-TS-G-D
In Commercial Distribution

  • B286FHCSWC1824TSGD1 ()
FHCSWC1824-TS-G-D

  • Blanket warming cabinet, dry-heat
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