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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 Head Sizing Plate is used to find the base width, along with the need for a concentric or eccentric head, prior to trialing the humeral head.
Ascension Orthopedics, Inc.
HSP-0923-070-004
In Commercial Distribution

  • M269HSP09230700041 ()
  • 10381780124603 ()

  • Size 44; 1.732 in dia
HSP-0923-070-004

  • Surgical implant template, reusable
The Head Sizing Plate is used to find the base width, along with the need for a concentric or eccentric head, prior to trialing the humeral head.
Ascension Orthopedics, Inc.
HSP-0923-070-003
In Commercial Distribution

  • M269HSP09230700031 ()
  • 10381780124597 ()

  • Size 42; 1.654 in dia
HSP-0923-070-003

  • Surgical implant template, reusable
The Head Sizing Plate is used to find the base width, along with the need for a concentric or eccentric head, prior to trialing the humeral head.
Ascension Orthopedics, Inc.
HSP-0923-070-002E
In Commercial Distribution

  • M269HSP0923070002E1 ()
  • 10381780124580 ()

  • Size 40E; 1.6 in dia
HSP-0923-070-002E

  • Surgical implant template, reusable
The Head Sizing Plate is used to find the base width, along with the need for a concentric or eccentric head, prior to trialing the humeral head.
Ascension Orthopedics, Inc.
HSP-0923-070-001E
In Commercial Distribution

  • M269HSP0923070001E1 ()
  • 10381780124573 ()

  • Size38-E; 1.5 in dia
HSP-0923-070-001E

  • Surgical implant template, reusable
The Head Sizing Plate is used to find the base width, along with the need for a concentric or eccentric head, prior to trialing the humeral head.
Ascension Orthopedics, Inc.
HSP0920070008
In Commercial Distribution

  • M269HSP09200700081 ()
  • 10381780124566 ()

  • Size 52; 2.047 in dia


  • Surgical implant template, reusable
The Head Sizing Plate is used to find the base width, along with the need for a concentric or eccentric head, prior to trialing the humeral head.
Ascension Orthopedics, Inc.
HSP0920070007
In Commercial Distribution

  • M269HSP09200700071 ()
  • 10381780124559 ()

  • Size 50; 1.969 in dia


  • Surgical implant template, reusable
The Head Sizing Plate is used to find the base width, along with the need for a concentric or eccentric head, prior to trialing the humeral head.
Ascension Orthopedics, Inc.
HSP0920070006
In Commercial Distribution

  • M269HSP09200700061 ()
  • 10381780124542 ()

  • Size 48; 1.890 in dia


  • Surgical implant template, reusable
The Head Sizing Plate is used to find the base width, along with the need for a concentric or eccentric head, prior to trialing the humeral head.
Ascension Orthopedics, Inc.
HSP0920070005
In Commercial Distribution

  • M269HSP09200700051 ()
  • 10381780124535 ()

  • Size 46; 1.811 in dia


  • Surgical implant template, reusable
The Head Sizing Plate is used to find the base width, along with the need for a concentric or eccentric head, prior to trialing the humeral head.
Ascension Orthopedics, Inc.
HSP0920070004
In Commercial Distribution

  • M269HSP09200700041 ()
  • 10381780124528 ()

  • Size 44; 1.732 in dia


  • Surgical implant template, reusable
The PHYSIQ 360 is a diode laser device. The device is provided with 4 applicators that deliver the laser energy to the patient (to subcutaneous tissue layers).
DEKA M.E.L.A. SRL
M134A1
In Commercial Distribution

  • 08057017760689 ()
M134A1

  • General/multiple surgical diode laser system
The separation prisms is an accessory to the tonometer which is device intended to estimate intraocular pressure by applying a force on the globe of the eye.
LUNEAU TECHNOLOGY OPERATIONS
Tonometer separation prisms L900 -box of 20
In Commercial Distribution

  • 03664188000114 ()
  • 03664188000138 ()


  • Ophthalmic tonometer tip cover
The separation prisms is an accessory to the tonometer which is device intended to estimate intraocular pressure by applying a force on the globe of the eye.
LUNEAU TECHNOLOGY OPERATIONS
Tonometer separation prisms L900 -box of 100
In Commercial Distribution

  • 03664188000107 ()
  • 03664188000114 ()


  • Ophthalmic tonometer tip cover
The Patient Tracker EM mini provides a reference point on the patient. This reference defines the patient location and is used to correlate the patient anatomy to the image set. The Patient Tracker connects to the Navigation Unit via an integrated cable. The Patient Tracker EM mini is provided non-sterile and is intended to be sterilized by the user. The Patient Tracker EM mini is reusable.
Scopis GmbH
1.0
In Commercial Distribution

  • B057U1031120 ()
U1 031 12

  • Patient positioning sensor
The straight guide is used to lead intramedullary reamer in its proper course into the medullary canal. The end piece permits to prevent and retain the intramedullary reamer in case of sliding along the guide. The length varies from 440 to 820 mm and the diameter from 2 to 3 mm. Two kind of head, permitting to maintain the intramedullary reamer, exist. This is a reusable device.
MPS Micro Precision Systems AG
T602
In Commercial Distribution

  • 07640187911343 ()
T602

  • Orthopaedic guidewire, reusable
The Uni-Fit Extender is a high quality, commercial grade installation accessory to be used with the SuperPole. The Uni-Fit Extender is intended to increase the floor to ceiling range of the SuperPole from 93-99" to 100-120" (236-251cm to 254-305cm). The Uni-Fit Extender is a metal tube that attaches between the top plate and the pole assembly of the SuperPole. The Uni-Fit Extender features a series of holes that can be selected depending on the desired floor to ceiling height range. The Uni-Fit Extender is only to be used with HealthCraft’s SuperPole System. The Uni-Fit Extender is not to be used with the SuperTrapeze, SuperPole Bariatric or SuperPole Ultra. The Uni-Fit Extender is not to be used in any other way than described.
Healthcraft Products Inc.
SP-UF
In Commercial Distribution

  • 00689281019224 ()
01922

  • Hand rail
The OR Base Station subsystem is intended to send and receive data to and from the CTE implant over a wireless communication interface. Data sent to the CTE implant from the OR Base Station activates the CTE implant on the day of surgery.
Canary Medical USA LLC
43-5570-002-14
In Commercial Distribution

  • 00860003118313 ()


  • Medical networking interface unit
The Fitted Vest is designed to carry a CADD-Legacy® 1400 pump. The Fitted Vest is intended to be an undergarment layer that holds the pump close to the body. The Fitted Vest features a central zipper that rises fully up the torso.
ABBVIE INC.
0AV551
In Commercial Distribution

  • 38054083022520 ()
  • 08054083022529 ()


  • Personal device holder, reusable
The Fitted Vest is designed to carry a CADD-Legacy® 1400 pump. The Fitted Vest is intended to be an undergarment layer that holds the pump close to the body. The Fitted Vest features a central zipper that rises fully up the torso.
ABBVIE INC.
0AV551
In Commercial Distribution

  • 38054083022483 ()
  • 08054083022482 ()


  • Personal device holder, reusable
The Fitted Vest is designed to carry a CADD-Legacy® 1400 pump. The Fitted Vest is intended to be an undergarment layer that holds the pump close to the body. The Fitted Vest features a central zipper that rises fully up the torso.
ABBVIE INC.
0AV551
In Commercial Distribution

  • 38054083022476 ()
  • 08054083022475 ()


  • Personal device holder, reusable
The Fitted Vest is designed to carry a CADD-Legacy® 1400 pump. The Fitted Vest is intended to be an undergarment layer that holds the pump close to the body. The Fitted Vest features a central zipper that rises fully up the torso.
ABBVIE INC.
0AV551
In Commercial Distribution

  • 38054083022469 ()
  • 08054083022468 ()


  • Personal device holder, reusable
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