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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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The peritoneal catheter is used to drain cerebrospinal fluid from the outlet of the valve unit into the peritoneum. The distal end of the catheter has four staggered rows of 6-mm slits, which are not readily visible. If the distal outlet hole of the catheter becomes obstructed, the slits open for drainage. The slits perform optimally in a saline environment after soaking for 24 hours at 37 degrees Celsius.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
9MD101
Not in Commercial Distribution

  • 10381780035664 ()
  • M2729MD1011 ()

  • 120cm Length x 2.7mm O.D. x1.4mm I.D. (F8)
9MD101

  • Peritoneal/atrial cerebrospinal fluid catheter
The peritoneal catheter is used to drain cerebrospinal fluid from the outlet of the valve unit into the peritoneum. The distal end of the catheter has four staggered rows of 6-mm slits, which are not readily visible. If the distal outlet hole of the catheter becomes obstructed, the slits open for drainage. The slits perform optimally in a saline environment after soaking for 24 hours at 37 degrees Celsius.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
953101
Not in Commercial Distribution

  • 10381780034308 ()
  • M2729531011 ()

  • 91cm Length x 2.3mm O.D. x 1.1mm I.D. (F7)
953101

  • Peritoneal/atrial cerebrospinal fluid catheter
Esthet-X®flow Liquid Micro Hybrid Compula® Tips Introductory Kit
DENTSPLY INTERNATIONAL INC.
648101
Not in Commercial Distribution

  • D0026481011 ()

  • 24 Tips, 1 Tips Gun, 1 Syringe Tooth Cond Gel, 25 Applicator Needles, 20 Unit Doses Adhesive, 1 Unit Dose Holder, 20 Applicator Tips, Enhance Finishing Sample, Polishing Sample, Tips Sample
  • Weight: 0.25 Gram
648101

  • Dental composite resin
The aiACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The aiACT test is an activated whole blood clotting time test which uses a blend of celite and clay for contact activation. It may also be used with citrated whole blood. The aiACT Kit is only intended for high dose (ACT greater or equal to 400 seconds, on Sonoclot Analyzer) heparin anticoagulation management as typically encountered during cardiopulmonary bypass surgery. The aiACT test provides ACT results that are substantially unaffected by aprotinin. When used with the Sonoclot Analyzer System, the aiACT test provides quantitative Onset/ACT and Clot Rate results. Do not use the aiACT test for platelet function assessment. Each kit contains 24 lidded yellow plastic activation cuvettes, 24 probes, and instructions for use. The activation cuvettes contain a controlled amount of contact activator and a magnetic stir bar.
SIENCO, INC.
800-0441
In Commercial Distribution

  • B55880004410 ()
  • B55880004411 ()
800-0441

  • Multiple coagulation factor IVD, kit, clotting
Overall size 24”W x 20.5”D x 64.75"T Upper Chamber I.D. 20”W x 17”D x 13.5”T 2.65 Cubic ft. storage. Lower chamber I.D. 20 “W x 17”D x 24.5”T 4.80 Cubic ft. storage. Digital control. 3 Adjustable shelves. Audible and visual over-temp alarm. Glass Doors Accuracy +/- 1 degrees F (upper chamber). Accuracy +/- 2 degrees F (lower chamber). Electrical: 220V UL/CUL listed. Keyed temperature lock. Foot levelers
FUTURE HEALTH CONCEPTS, INC.
FHCDWC2460-TL-G-D-220
In Commercial Distribution

  • B337FHCDWC2460TLGD2201 ()
FHCDWC2460-TL-G-D-220

  • 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 Digital control. Glass door Audible and visual over-temp alarm. Keyed temperature lock for each chamber Electronic Locking door Data Logger Foot levelers No base Electrical: 120V, 3.5 Amp, 50/60 Hz. .45kw/hr, 1537 btu/hr. UL/CUL listed FDA Registered
M.A.C. MEDICAL INC.
W2024XSS-G-NB-BWEL
In Commercial Distribution

  • B286W2024XSSGNBBWEL1 ()
W2024XSS-G-NB-BWEL

  • Blanket warming cabinet, dry-heat
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 Mobile base 3 Adjustable shelves Digital control Glass door Data Logger Door Lock Keyed temperature lock Audible and visual over-temp alarm Electrical: 120V, 7.5 Amp, 50/60 Hz .49kw/hr, 1678 btu/hr UL/CUL listed FDA Registered
M.A.C. MEDICAL INC.
W2024XSS-G-MB
In Commercial Distribution

  • B286W2024XSSGMB1 ()
W2024XSS-G-MB

  • Blanket warming cabinet, dry-heat
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 Mobile base 3 Adjustable shelves Digital control Glass door Data Logger Door Lock Keyed temperature lock Audible and visual over-temp alarm Electrical: 120V, 7.5 Amp, 50/60 Hz .49kw/hr, 1678 btu/hr UL/CUL listed FDA Registered
M.A.C. MEDICAL INC.
W2024MS-G-MB
In Commercial Distribution

  • B286W2024MSGMB1 ()
W2024MS-G-MB

  • Blanket warming cabinet, dry-heat
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 4" Base 3 Adjustable shelves Digital control Glass door Data Logger Door Lock Keyed temperature lock Audible and visual over-temp alarm Electrical: 120V, 7.5 Amp, 50/60 Hz .49kw/hr, 1678 btu/hr UL/CUL listed FDA Registered
M.A.C. MEDICAL INC.
W2024MS-G-4B
In Commercial Distribution

  • B286W2024MSG4B1 ()
W2024MS-G-4B

  • Blanket warming cabinet, dry-heat
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 Stainless steel door Audible and visual over-temp alarm Key temp lock Door lock Foot levelers No base Electrical: 120V, 7.5 Amp, 50/60 Hz .49kw/hr, 1678 btu/hr UL/CUL listed FDA Registered
M.A.C. MEDICAL INC.
SWC182464-NB
In Commercial Distribution

  • B286SWC182464NB1 ()
SWC182464-NB

  • Blanket warming cabinet, dry-heat
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