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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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Anti-D Series 5 (Monoclonal Blend) is intended for use in slide, tube, microplate and automated tests, for the detection of the Rh (D) antigen.
IMMUCOR, INC.
0006415
In Commercial Distribution

  • 10888234002017 ()
0006415

  • Anti-Rh(D) red blood cell grouping IVD, antibody
Anti-D Series 5 (Monoclonal Blend) is intended for use in slide, tube, microplate and automated tests, for the detection of the Rh (D) antigen.
IMMUCOR, INC.
0006414
In Commercial Distribution

  • 10888234000563 ()
0006414

  • Anti-Rh(D) red blood cell grouping IVD, antibody
Content: 1 piece Height: 22 mm Highly translucent zirconia for single crowns and small bridges (fully anatomic structures or reduced structures for veneering with ceramics)
ZIRKONZAHN SRL
ZRAD5301
In Commercial Distribution

  • D800ZRAD5301 ()


  • Dental bridge, ceramic
Content: 3 pieces Height: 16 mm Translucent zirconia for single crowns and small bridges (reduced structures for veneering with ceramics)
ZIRKONZAHN SRL
ZRAB0301
In Commercial Distribution

  • D800ZRAB0301 ()


  • Dental bridge, ceramic
MultiStim, (TR) 3" x 5", Cloth, (2/pk)
COMPASS HEALTH BRANDS CORP.
400-8522
In Commercial Distribution

  • 30092237622255 ()
  • 00092237622254 ()
  • 01092237622253 ()
  • 80092237622250 ()


  • Transcutaneous electrical stimulation electrode, single-use
No Description
Bio/Data Corporation
107650
In Commercial Distribution

  • G0561076501 ()
107650

  • Platelet aggregation study IVD, kit, nephelometry/turbidimetry
#5- Spatula Dissector, Medium, 2.0mm
KATALYST SURGICAL LLC
N084-080
In Commercial Distribution

  • 00840096203943 ()


  • General-purpose surgical spatula
StatusFirst™ ME/O(2K)/C/TH/P card; 25 Test kit; for reader
PRINCETON BIOMEDITECH CORPORATION
DOA-251-25-02
In Commercial Distribution

  • 10743816000396 ()
DOA-251-25-02

  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
Set of 5 Iris Retractors
AKTIVE SRL
AK-0492
In Commercial Distribution

  • 08056477550502 ()
  • 08052276027061 ()

  • GAUGE
AK-0492

  • Intraocular retractor, single-use
Silver-coated antimicrobial barrier dressing
SMITH & NEPHEW MEDICAL LIMITED
66800405
In Commercial Distribution

  • 00040565124483 ()
  • 00040565124339 ()
  • 30040565124484 ()
66800405

  • Wound-nonadherent dressing, absorbent, antimicrobial
Content: 1 piece Height: 16 mm High-quality medical titanium alloy (Ti-6Al-4V ELI according to ASTM F136 and ISO 5832-3) for the production of metal structures for veneering with ceramic as well as bars and implant constructions. Info: our Titan has a new name: Titanit. Properties and range of applications remain unchanged.
ZIRKONZAHN SRL
MEAL98S16
In Commercial Distribution

  • D800MEAL98S16 ()


  • Dental bridge, metal-ceramic
Content: 1 piece Height: 14 mm High-quality medical titanium alloy (Ti-6Al-4V ELI according to ASTM F136 and ISO 5832-3) for the production of metal structures for veneering with ceramic as well as bars and implant constructions. Info: our Titan has a new name: Titanit. Properties and range of applications remain unchanged.
ZIRKONZAHN SRL
MEAL98S14
In Commercial Distribution

  • D800MEAL98S14 ()


  • Dental bridge, metal-ceramic
Content: 1 piece Height: 18 mm High-quality medical titanium alloy (Ti-6Al-4V ELI according to ASTM F136 and ISO 5832-3) for the production of metal structures for veneering with ceramic as well as bars and implant constructions. Info: our Titan has a new name: Titanit. Properties and range of applications remain unchanged.
ZIRKONZAHN SRL
MEAL98S18
In Commercial Distribution

  • D800MEAL98S18 ()


  • Dental bridge, metal-ceramic
Content: 20 g
ZIRKONZAHN SRL
KEAD6342
In Commercial Distribution

  • D800KEAD63420 ()


  • Dental appliance fabrication material, ceramic
Content: 20 g
ZIRKONZAHN SRL
KEAD6342
In Commercial Distribution

  • D800KEAD6342 ()


  • Dental appliance fabrication material, ceramic
Content: 10 g Ceramic pastes for veneering zirconia structures in the gingival region. Colour spectrum: from very light pink (Fresco Gingiva 1) to very dark red (Fresco Gingiva 6).
ZIRKONZAHN SRL
KEAD6341
In Commercial Distribution

  • D800KEAD63410 ()


  • Dental appliance fabrication material, ceramic
Content: 10 g Ceramic pastes for veneering zirconia structures in the gingival region. Colour spectrum: from very light pink (Fresco Gingiva 1) to very dark red (Fresco Gingiva 6).
ZIRKONZAHN SRL
KEAD6341
In Commercial Distribution

  • D800KEAD6341 ()


  • Dental appliance fabrication material, ceramic
No Description
Lonza Walkersville, Inc.
WPW-045F
In Commercial Distribution

  • 00840075403685 ()
WPW-045F

  • Ex vivo cell culture medium
No Description
Lonza Walkersville, Inc.
WPW-045D
In Commercial Distribution

  • 00840075403678 ()
WPW-045D

  • Ex vivo cell culture medium
No Description
Lonza Walkersville, Inc.
08-735D
In Commercial Distribution

  • 00840075402671 ()
08-735D

  • Ex vivo cell culture medium
No Description
Lonza Walkersville, Inc.
08-735B
In Commercial Distribution

  • 00840075401377 ()
08-735B

  • Ex vivo cell culture medium
The Showmotion UPPER 5 kit includes 5 WISE sensors, a GATEWAY receiver, elastic bands and a charger. The platform allows to carry out the kinematic analysis of the movement of the upper district.
NCS LAB SRL
SHWM01U5
In Commercial Distribution

  • 08051122041022 ()


  • Kinesiology/electromyographic sensor set
Content: 100 g
ZIRKONZAHN SRL
KEAA6242
In Commercial Distribution

  • D800KEAA6242 ()


  • Dental appliance fabrication material, ceramic
Content: 20 g Colour scale from very bright (Tissue 1) to very dark (Tissue 6)
ZIRKONZAHN SRL
KEAA6241
In Commercial Distribution

  • D800KEAA6241 ()


  • Dental appliance fabrication material, ceramic
Coil for Artoscan
ESAOTE SPA
9102000000
In Commercial Distribution

  • 08056304453396 ()


  • MRI system coil, radio-frequency
Coil for E-scan XQ
ESAOTE SPA
9102206001
In Commercial Distribution

  • 08056304453327 ()


  • MRI system coil, radio-frequency
Coil for C-scan
ESAOTE SPA
9101645000
In Commercial Distribution

  • 08056304453228 ()


  • MRI system coil, radio-frequency
No Description
Sonova AG
(velvet black)
In Commercial Distribution

  • 07613389718188 ()
050-1094-P867

  • Air-conduction hearing aid, receiver-in-canal
No Description
Sonova AG
(silver gray)
In Commercial Distribution

  • 07613389718171 ()
050-1094-P667

  • Air-conduction hearing aid, receiver-in-canal
No Description
Sonova AG
(sand beige)
In Commercial Distribution

  • 07613389718164 ()
050-1094-P167

  • Air-conduction hearing aid, receiver-in-canal
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