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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 SPIN SNAP-OFF SCREW is a self drilling and self tapping snap-off screw. One part is fixed on a standard surgical power equipment and when the snap-off screw is totally introduced in the bone, her head is blocked and the breaking torque is enough important to cause dissociation between the screw and the snap-off. It comes in lengths from 11 to 14mm and it is available in 2.0mm and 2.7mm diameters. It is made from Titanium alloy and it is delivered sterile.
NEWDEAL
112113SND
In Commercial Distribution

  • 10381780047445 ()
  • M248112113SND1 ()

  • 2.7mm diam. x 13mm length
112113SND

  • Orthopaedic bone screw, non-bioabsorbable, sterile
The SPIN SNAP-OFF SCREW is a self drilling and self tapping snap-off screw. One part is fixed on a standard surgical power equipment and when the snap-off screw is totally introduced in the bone, its head is blocked and the breaking torque is important enough to cause dissociation between the screw and the snap-off. It comes in lengths from 11 to 14mm and it is available in 2.0mm and 2.7mm diameters. It is made from Titanium alloy and it is delivered non sterile.
NEWDEAL
112113ND
In Commercial Distribution

  • M248112113ND1 ()
  • 10381780047438 ()

  • 2.7mm diam. x 13mm length
112113ND

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The SPIN SNAP-OFF SCREW is a self drilling and self tapping snap-off screw. One part is fixed on a standard surgical power equipment and when the snap-off screw is totally introduced in the bone, her head is blocked and the breaking torque is enough important to cause dissociation between the screw and the snap-off. It comes in lengths from 11 to 14mm and it is available in 2.0mm and 2.7mm diameters. It is made from Titanium alloy and it is delivered sterile.
NEWDEAL
112112SND
In Commercial Distribution

  • 10381780047421 ()
  • M248112112SND1 ()

  • 2.7mm diam. x 12mm length
112112SND

  • Orthopaedic bone screw, non-bioabsorbable, sterile
The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the power of an IOL for cataract surgery such as axial length, corneal curvature radius, and anterior chamber depth. It measures these necessary values successively through a non-contact optical measurement method. An optional A-scan probe is also available to scan axial length with an ultrasonic measurement function by touching it to the cornea should optical measurement not be successful. In addition, an anterior eye segment image overlaid with the corneal meridians can be created as a reference for toric IOL implantation. The AL-Scan also has the function to calculate the power of an IOL using measured values such as axial length.
NIDEK CO.,LTD.
AL-Scan
In Commercial Distribution

  • 04987669100547 ()


  • Optical pachymeter
  • Ophthalmic examination slit lamp
  • Bench-top keratometer
  • Ophthalmic ultrasound imaging system
Universal Tenodesis Disposable Procedure Pack
Medshape, Inc.
1500-02-000
In Commercial Distribution

  • M9701500020000 ()


  • Orthopaedic bone wire
  • Suturing unit, single-use
  • Suture knot pusher, single-use
  • Ligament graft sizer, noninvasive
Pelvic Health Device is one of a new breed of modern Neuromuscular Stimulators (STIM) developed with the aim of achieving optimum pelvic health for women. Our principle aim is to design a product to give women the opportunity to exercise their muscles, strengthen weak muscles and nerve fibres in a compact, easy to use device - we also wanted the device to be able to be versatile enough so that as a woman achieve greater muscle control, with high levels of functional use, are sensibly priced, compact and user friendly.
Shenzhen Konmed Technology Co., Ltd.
KM518
In Commercial Distribution

  • 06970935830017 ()


  • Perineal orifice incontinence-control electrical stimulation system
Apligraf is indicated for use with standard therapeutic compression for the treatment of non-infected partial and full thickness skin ulcers due to venous insufficience of greater than one month duration and which have not adequately responded to conventional ulcer therapy. Apligraf is also indicated for use with standard diabetic foot ulcer care for the treatment of full-thickness neuropathic diabetic foot ulcers of greater than three weeks duration which have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure.
ORGANOGENESIS INC.
1
In Commercial Distribution

  • 00618474000008 ()


  • Skin regeneration template, human-/animal-derived
GlabrataQuick™, for the identification of Candida glabrata, 24 tests GlabrataQuick™, contains two 96 well trays and 24 Inoculation Buffer tubes with 1ml fill to complete a total of 24 tests. GlabrataQuick™ will accurately identify Candida glabrata within one to two hours. It tests for three carbohydrates for greater accuracy; trehalose, sucrose, and maltose. Easy and distinct color read-out. Carbohydrates turn from blue to yellow. A great test to use in conjunction with the HardyCHROM Candida plate (cat. no. G301). Contains: GlabrataQuick Reaction Strips (24) 00819398027595 GlabrataQuick Inoculation Buffer, 1ml (24) 00819398028684
HARDY DIAGNOSTICS
Z298
In Commercial Distribution

  • 00819398028691 ()
Z298

  • Candida albicans/C. glabrata antigen IVD, kit, agglutination, rapid
The MIS Precision Chevron Bunion System™ is a kit designed to allow surgeons to perform a chevron bunion osteotomy, and subsequent fixation of the osteotomy, with a minimally invasive surgical technique. The MIS Precision Chevron Bunion System™ consists of a single, sterile-packaged SKU that contains both implants and instruments needed for the procedure. The implants in the kit are cannulated headless compression screws, made from titanium (Ti-6AL-4V ELI). There are two implants in the kit, however only one is used in a surgical procedure. Two implants are provided to allow the physician to select the proper size for the patient at the time of surgery. The implants are 3.5 mm diameter, with lengths of 24 mm and 27 mm. There are also single-use instruments, made of injection molded polycarbonate, PEEK, and stainless steel included in the MIS Precision Chevron Bunion System™. Instruments include an osteotomy guide (one each for left and right feet), a targeting guide, a screw guide, screwdriver, drill bit, and several K-wires and a guidewire. Additional general surgical instrumentation is utilized, but not part of the RELJA system, such as sagittal saw, drivers, and scalpel.
Relja Innovations LLC
RI-2427-C
In Commercial Distribution

  • 00860005968800 ()


  • Orthopaedic bone screw, non-bioabsorbable, sterile
primaLOK SP 18mm Implant Assembly, Sterile The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use.
Wenzel Spine, Inc.
800-0118-00
In Commercial Distribution

  • 00813210021778 ()

  • Height: 18 Millimeter


  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial
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