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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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Ti6 Headless - TH-Series Screws (Titanium Headless) is a cannulated, dual-thread, headless bone screw used in the Integra® Ti6® Internal Fixation System
Ascension Orthopedics, Inc.
TH2514
In Commercial Distribution

  • 10381780115335 ()
  • M268TH25141 ()

  • 14 mm L x 2.5 mm dia; 6 mm thread
TH2514

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Ti6 Headless - TH-Series Screws (Titanium Headless) is a cannulated, dual-thread, headless bone screw used in the Integra® Ti6® Internal Fixation System
Ascension Orthopedics, Inc.
TH2512
In Commercial Distribution

  • 10381780115328 ()
  • M268TH25121 ()

  • 12 mm L x 2.5 mm dia; 4.85 mm thread
TH2512

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The uTYPE™ CDx HLA Sequence Analysis Software is intended to analyze sequencing data generated from the SeCore™ CDx HLA Sequencing system
ONE LAMBDA, INC.
UTPCDX-PGR
In Commercial Distribution

  • 00812117016849 ()
UTPCDX-PGR

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
WASHER DISINFECTOR 46-4-403 D+WD, D+WD indicating double door + dryer. Cat no was 46-4-403. From March 2019 new cat no is 46-4-503.
Getinge Disinfection AB
46-4
In Commercial Distribution

  • 07340153700048 ()
46-4-503

  • Surgical utensil washer/disinfector
The APA™ Video Laryngoscope is a multi-functional device designed to assist direct and indirect laryngoscopy in routine and difficult airway intubations. It may be used to facilitate endotracheal intubation as part of general anaesthesia or CPR (cardiopulmonary resuscitation) during cardiac arrest. The video laryngoscope is reusable, DEHP-free and latex-free. It is fully detachable into three components: APA™ Video Viewer, APA™ Handle and APA™ MAC or MIL Camera Module(Small and Large size). When used as a standard laryngoscope, the appropriate Camera Module is attached to the Handle to obtain a view of the laryngeal inlet during endotracheal intubation. When used as a video laryngoscope, the Video Viewer is attached to the Handle and Camera Module to provide improved visualisation during laryngoscopy and endotracheal intubation.
VENNER MEDICAL (SINGAPORE) PTE. LTD.
702930
In Commercial Distribution

  • 28885009190237 ()
  • 08885009190233 ()
702930

  • Rigid intubation laryngoscope, reusable
The APA™ Video Laryngoscope is a multi-functional device designed to assist direct and indirect laryngoscopy in routine and difficult airway intubations. It may be used to facilitate endotracheal intubation as part of general anaesthesia or CPR (cardiopulmonary resuscitation) during cardiac arrest. The video laryngoscope is reusable, DEHP-free and latex-free. It is fully detachable into three components: APA™ Video Viewer, APA™ Handle and APA™ MAC or MIL Camera Module (Small and Large size). When used as a standard laryngoscope, the appropriate Camera Module is attached to the Handle to obtain a view of the laryngeal inlet during endotracheal intubation. When used as a video laryngoscope, the Video Viewer is attached to the Handle and Camera Module to provide improved visualisation during laryngoscopy and endotracheal intubation.
VENNER MEDICAL (SINGAPORE) PTE. LTD.
702910
In Commercial Distribution

  • 08885009190226 ()
702910

  • Rigid intubation laryngoscope, reusable
The Disposable surgical mask (non sterile) is single use, three-layer, flat-pleated style with ear straps and nose piece. The mask is manufactured with three layers, the inner and outer layers are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. The ear straps are held in place over the users’ mouth and nose by two elastic ear straps welded to the facemask. The elastic ear straps are not made with natural rubber latex. The nose piece on the layers of facemask is to allow the user to fit the facemask around their nose, which is made of PE (polyethylene) with dual-Galvanized wire. The Disposable surgical mask (non sterile) will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.
Qinhuangdao Taizhi Medical Technology Co., Ltd.
ear strap, 175×95mm
In Commercial Distribution

  • 06973274100520 ()


  • Surgical/medical face mask, single-use
The STROPP (Single Tunnel Repair of Plantar Plate) System is a sterile packaged kit that include PEEK implants and related instruments for plantar plate repair. Implants are packaged with the following manual surgical instruments for general use: a needle, needle passer, suture passer, an inserter, K-wires and distractor. The implants are compatible with Size 0 suture; suture is not included with the system. The STROPP System is intended for use with a suture in metatarsal ligament and tendon repairs.
CROSSROADS EXTREMITY SYSTEMS
1601-0001
In Commercial Distribution

  • 00815432023264 ()

  • 3.0mm Diameter x 8.0mm Length
1601-0001

  • Suturing needle holder, single-use
  • Suturing needle holder, reusable
  • Orthopaedic surgical distractor, internal
  • Tendon/ligament bone anchor, non-bioabsorbable
  • Bone-resection orthopaedic reamer, reprocessed
  • Bone-resection orthopaedic reamer, single-use
  • Orthopaedic bone wire
  • Orthopaedic inorganic implant inserter/extractor, reusable
  • Suturing unit, single-use
  • Suturing needle, single-use
The STROPP (Single Tunnel Repair of Plantar Plate) System is a sterile packaged kit that include PEEK implants and related instruments for plantar plate repair. Implants are packaged with the following manual surgical instruments for general use: a needle, needle passer, suture passer, an inserter, K-wires and distractor. The implants are compatible with Size 0 suture; suture is not included with the system. The STROPP System is intended for use with a suture in metatarsal ligament and tendon repairs.
CROSSROADS EXTREMITY SYSTEMS
STRoPP Plantar Plate Repair Kit - Sterile
In Commercial Distribution

  • 00815432023097 ()

  • 3.0mm Diameter x 8.0mm Length
1601-0000

  • Suturing needle holder, single-use
  • Suturing needle holder, reusable
  • Orthopaedic surgical distractor, internal
  • Tendon/ligament bone anchor, non-bioabsorbable
  • Bone-resection orthopaedic reamer, reprocessed
  • Bone-resection orthopaedic reamer, single-use
  • Orthopaedic bone wire
  • Orthopaedic inorganic implant inserter/extractor, reusable
  • Suturing unit, single-use
  • Suturing needle, single-use
The CALCANEA Plate is a Titanium low profile anatomical plate dedicated for fixation of calcaneal fractures. It enables a reconstruction of height and width of the calcaneus and a possible remodeling to the lateral calcaneus. Its anatomical design provides optimal bone coverage while its low profile provides a minimal irritation of soft tissues. The plate is available in three different sizes for optimal anatomical fit and it is delivered non sterile. Numerous holes enable versatile screw fixation.
NEWDEAL
180030ND
Not in Commercial Distribution

  • M248180030ND1 ()
  • 10381780043874 ()

  • 73mm length x 37mm width
180030ND

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
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