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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Hand held shower head, chrome
WATER PIK, INC.
XAT-643E
In Commercial Distribution

  • 00073950251259 ()
XAT-643E

  • External manual massager, home-use
OMBREDANNE Mallet, 9 1/2" (240 mm), diam. 40 mm, peek handle, stainless steel, 900 g, 550 g
Aesculap AG
FL066R
In Commercial Distribution

  • 04038653167128 ()
FL066R

  • Surgical mallet
EYE PACK
MEDLINE INDUSTRIES, INC.
DYNJ50961
In Commercial Distribution

  • 10889942106639 ()
DYNJ50961

  • General surgical procedure kit, medicated
BABY KIT
MEDLINE INDUSTRIES, INC.
DYKB1014
In Commercial Distribution

  • 10889942650927 ()
DYKB1014

  • General surgical procedure kit, non-medicated, single-use
HAND PACK
Cardinal Health 200, LLC
SOP43HPMAD
In Commercial Distribution

  • 50888439828199 ()
  • 10888439828191 ()
SOP43HPMAD

  • Orthopaedic surgical procedure kit, medicated
Poseidon Poly-axial Screw D3.5mm x L20mm
Medyssey Co., Ltd.
LPP3520
In Commercial Distribution

  • 08809214548061 ()


  • Vertebral body prosthesis, non-sterile
The AnyPlus Spinal Fixation System consists of various hooks, screws, rods and connectors and is intended to create a rigid spinal construct. The components are manufactured from Ti6AI4V ELI according to ISO 5832-3 and ASTM F-136. The screws are available from 4.0 to 10.5mm diameters with lengths ranging from 20 to 100mm (Length does not include the screw head). Specialized instruments are available for the application and removal of the Anypluss Spinal Fixation System. AnyPlus Spinal Fixation System are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1 -S2), a posterior hook fixation system (T 1-5), or as a anterolateral fixation system (T8-L_5). All components in the system are limited to skeletally mature patients. System components are to be used for immobilization and stabilization of the spine as an adjunct to fusion. These devices are indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion.
GS Medical Co., Ltd.
0942-7025
In Commercial Distribution

  • 08806378325286 ()
0942-7025

  • Bone-screw internal spinal fixation system, non-sterile
PWDII70SF AIM CL K3 16
MAQUET SAS
ARDPWT209102A
In Commercial Distribution

  • 03700712406233 ()


  • Operating room light
No Description
Design Eyewear Group International A/S
FFSWIMM2/009
In Commercial Distribution

  • 03663524080926 ()


  • Tinted non-prescription spectacles
3.5 Cortex Screw, hex, tapping, TI, L _x000D_36 mm _x000D_
mahe medical gmbh
001-0004-036ST
In Commercial Distribution

  • 04050659165113 ()


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
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