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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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otosil ES-1.1 - EPRCA0030680

ES-1.1 / 25 Shore violet 8 double cartridges with 48 ml each
pro3dure medical GmbH
Shore 25 / 8 double cartridges of 2 x 24 ml - violet
In Commercial Distribution

  • EPRCA0030680 ()
A0033427

  • Earmould, custom-made

FusionMAX Spine Table - 00840343716424

The FusionMAX™ Table is a mobile surgery table designed for temporary support (<24 hours) and positioning of a patient in a prone, supine, or lateral position. The Table is intended for use during surgical procedures, including radiographic imaging during such procedures. The Table is not intended for use in patient transport.
SURGIX MEDICAL LLC
33501
In Commercial Distribution

  • 00840343716424 ()


  • Orthopaedic operating table, electromechanical

Matching Limb Protection Sleeves - Easi-Fit BFR - M995979503001

Delfi Matching Limb Protection Sleeves (MLPS) help protect the patient’s limb from possible wrinkling, pinching and shearing of skin and soft tissues of the limb. Each Delfi Matching Limb Protection Sleeve is intended for use with a specific Delfi tourniquet cuff. This is a multi-pack set (4 of each 18"/24"/34").
Delfi Medical Innovations Inc
9-7950-300
In Commercial Distribution

  • M995979503001 ()
  • M995979503000 ()


  • Stockinette

Profile-ESP Bolster - 00868579000261

The Profile-ESP Bolster device is an optional patient positioning accessory for use within the Profile-ESP workflow of the VMA System. The patient's pelvis is secured while performing the indicated spinal flexion and extension bending. The dimensions are approximately 40-47” wide (adjustable width), 24” deep, 42-58” tall (adjustable height). Weight is approximately 98 lbs. (44 kg).
ORTHO KINEMATICS, INC.
3.0
In Commercial Distribution

  • 00868579000261 ()


  • Basic diagnostic x-ray system table, non-powered

Easi-Fit BFR, Reusable - M995975500241

Delfi tourniquet cuffs are available in various models for pediatric to bariatric patients. Available in a selection of lengths and widths to facilitate proper fit, and color coded for size and identification. Reusable tourniquet cuffs must be inspected before use. This product is subject to wear and deteriorates with use. Size (WxL) 24" x 4.5" Contour.
Delfi Medical Innovations Inc
9-7550-024
In Commercial Distribution

  • M995975500241 ()


  • Tourniquet cuff, reusable

SINGLE CHAMBER WARMING CABINET - B286SWC182424NB2201

Overall size 24”W x 20.5”D x 6 x 24.5”T. Chamber I.D. 20”W x 17”D x 15.25”T. 3.0 Cubic ft. storage. Digital control. Data Logger Keyed temperature lock Door lock Optional adjustable shelve. Foot levelers. Stainless steel door Audible and visual over-temp alarm. No base Accuracy +/- 1 degrees F. Electrical: 220V Celcius
M.A.C. MEDICAL INC.
SWC182424-NB-220
In Commercial Distribution

  • B286SWC182424NB2201 ()
SWC182424-NB-220

  • Blanket warming cabinet, dry-heat

SINGLE CHAMBER WARMING CABINET - B286SWC182424GNB220UKC1

Overall size 24”W x 20.5”D x 6 x 24.5”T. Chamber I.D. 20”W x 17”D x 15.25”T. 3.0 Cubic ft. storage. Digital control. Data Logger Keyed temperature lock Door lock Optional adjustable shelve. Foot levelers. Full view glass door. Audible and visual over-temp alarm. Accuracy +/- 1 degrees F. Electrical: 220V United Kingdom Plug Celcius
M.A.C. MEDICAL INC.
SWC182424-G-NB-220UK-C
In Commercial Distribution

  • B286SWC182424GNB220UKC1 ()
SWC182424-G-NB-220UK-C

  • Blanket warming cabinet, dry-heat

CarboFerm™ - 00816576029068

CarboFerm™ I, rapid carbohydrate test for Neisseria and Moraxella, 24 tests per kit For the rapid identification and differentiation of Neisseria spp., including N. gonorrhoeae and N. meningitidis, and Moraxella (Branhamella) catarrhalis. CarboFerm™ uses acid production from carbohydrates to differentiate and identify Neisseria species and M. catarrhalis. Performs a glucose, lactose, maltose, sucrose, and butyrate test
HARDY DIAGNOSTICS
Z98
In Commercial Distribution

  • 00819398027632 ()
  • 00816576029068 ()
Z98

  • Multiple Haemophilus/Neisseria bacteria species culture isolate identification IVD, kit

Blue Diamond - 15060797551040

This Blue Diamond® Gel Pad is a pressure management pad. All our gel pads are made in the USA and are designed to mimic human adipose tissue composition to help prolong the chance of pressure insults. Because of the size of this pad it is ideal for a infant crib pad applications. 17" x 24" x 1/2"
David Scott Company
BD0100-172405
In Commercial Distribution

  • 15060797551040 ()
BD0100-172405

  • Operating table patient pressure distribution pad, reusable

otosil ES-1.1 - EPRCA0034127

ES-1.1 / 60 Shore neon-orange opaque 8 double cartridges with 48 ml each
pro3dure medical GmbH
Shore 60 / 8 double cartridges of 2 x 24 ml - neon-orange opaque
In Commercial Distribution

  • EPRCA0034127 ()
A0034127

  • Earmould, custom-made
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