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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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1.1mm K-wire, Instrument. The Vector Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
HAM-1001T-K11
In Commercial Distribution

  • 00810005666541 ()

  • Outer Diameter: 1.1 Millimeter


  • Bone tap, single-use, non-sterile
The HAMA IgG ELISA Test System is a direct enzyme-linked immunosorbent assay for the detection and semi-quantitation of human antibodies to mouse IgG (HAMA). The presence of human anti-mouse antibody (HAMA) has been associated with patients receiving injections of murine monoclonal antibody for diagnostic and/or therapeutic purposes.
ZEUS SCIENTIFIC, INC.
6401
In Commercial Distribution

  • 00845533001335 ()
6401

  • Human immunoglobulin G (IgG) murine conjugate antibody reagent IVD
A hand-held disposable device intended to be used by anaesthesia/emergency service personnel to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation.
ENTER MEDICAL CORPORATION
ENT-2002
In Commercial Distribution

  • 04719872102007 ()


  • Rigid intubation laryngoscope, single-use
The Integra Ti6 Internal Fixation System is comprised of Headless screws used for bone fixation of the hand and foot following trauma or osteotomy. The titanium headless screw is a cannulated dual-thread, headless bone screw which is offered in 2.5 and 3.0mm diameters with lengths of 10 to 24mm. The titanium quick snap is a snap-off solid core screw which is offered in 2.0mm and 2.7mm diameters with lengths of 8 to 22mm.The system includes titanium and stainless steel instruments to facilitate the placement of the screws.
Ascension Orthopedics, Inc.
TI6HLESSIMP
Not in Commercial Distribution

  • M268TI6HLESSIMP1 ()
  • 10381780074311 ()
TI6HLESSIMP

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
ThromboType assay is an assay for the molecular determination of HPA-1 (PlA), HPA-2 (Ko), HPA-3 (Bak), HPA-4 (Pen), HPA-5 (Br), HPA-6 (Ca), and HPA-15 (Gov), using PCR amplification of human genomic DNA.
IMMUCOR GTI DIAGNOSTICS, INC.
THROMBOTYPE
Not in Commercial Distribution

  • 10888234500285 ()
THROMBOTYPE

  • Multiple human platelet antigen (HPA) typing IVD, kit, multiplex
Flextrak OR is intended for allowing transfer of a neurosurgical patient from OR suite to MR suite and back with tools and instructions for proper positioning and MR imaging of those patients
Philips Medical Systems Nederland B.V.
Flextrak OR Ingenia 3.0T
In Commercial Distribution

  • 00884838112773 ()
781438

  • Patient transfer system, manual
Flextrak OR is intended for allowing transfer of a neurosurgical patient from OR suite to MR suite and back with tools and instructions for proper positioning and MR imaging of those patients
Philips Medical Systems Nederland B.V.
Flextrak OR Ingenia 1.5T
In Commercial Distribution

  • 00884838112766 ()
781437

  • Patient transfer system, manual
UniMatch PLUS Software analyzes the reaction patterns of UniTray™ and AllSet+™ Gold kits for the determination of Human Leukocyte Antigens (HLA) allele assignment by comparison to the IMGT/HLA database.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022496 ()
790111

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
Double Trocar K-wire, Instrument. The Vector Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
HAM-1001T-K12
In Commercial Distribution

  • 00810005667883 ()

  • Outer Diameter: 1.1 Millimeter


  • Bone tap, single-use, non-sterile
STRAP, LEG BAG, LATEX-FREE, VELCRO, UNIVERSAL, REUSABLE For use with most vinyl disposable or latex reusable leg bags. They are an economical alternative to the standard latex rubber straps packaged with most urine collection bags. An elastic/cotton & body construction allows the self-gripping fastener to attach itself along the length of the strap making it fully adjustable to individual requirements providing a safe, secure hold with a comfortable fit. A special blend of elastic and cotton makes them durable and allows them to be hand or machine washed. Set Contains: 2 Universal Leg straps and Illustrated Use and Care Instructions. * STRAPS NOT SOLD SEPARATELY ** BAGS MUST HAVE STRAP LOOPS/EYELETS FOR STRAPS TO PASS THROUGH
UROCARE PRODUCTS, INC.
6390
In Commercial Distribution

  • 10792293063905 ()
  • 00792293063908 ()

  • Weight: 0.06 Pound
  • Fits: 8" ~ 24" DIA. (20cm ~ 61cm Ø)
  • Universal, One size fits all Suitable for 44 fl. oz. (1,3 L) leg bags or smaller.
6390

  • Open-ended wearable urine collection bag, non-sterile
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