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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Male to Male Cannula Adaptor, Delrin, For Connecting Aspiration Cannulas to Aspiration Tubing
Med Saver, Inc.
5-5079-A
In Commercial Distribution

  • 00194613064440 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Mounting plate for Dräger power supply Delta, to mount to vertical wall channel
CIM med GmbH
DR-PS-4Z.1
In Commercial Distribution

  • 04061162056027 ()


  • Medical monitor/light mount
Option to the MAMMOMAT Inspiration FFDM system to acquire tomosynthesis images for mammography
Siemens Healthcare GmbH
11104944
In Commercial Distribution

  • 04056869001005 ()


  • Stationary mammographic x-ray system, digital
Spirometer sensor to measure inspiratory and expiratory pulmonary function for connection to software
eResearchTechnology GmbH
WSSU
In Commercial Distribution

  • 04057155000566 ()


  • Diagnostic spirometer, professional
Autoclavable teflon cable-end to connect Wolf/Storz cables to fit Sapimed's Self-Light grips.
SAPI MED SPA
Fiber cable adaptor
In Commercial Distribution

  • 08033638801192 ()
B.0365

  • Light source adaptor
dental Silane Bond Enhancer kit to enhance bond of restoration to tooth structure
CHAMELEON DENTAL PRODUCTS, INC
PBEK
In Commercial Distribution

  • MPBEK1 ()


  • Dental prosthesis priming agent
HERCULES W/3 ARMS 1 MED TO 7KG & 2 HEAVY TO 45 KG
AADCO MEDICAL, INC.
OS-31
In Commercial Distribution

  • 00840348501483 ()
OS-31

  • Custom-made medical device mount
V-Silicone Retainers, comes w/2 screws to fasten to lid, OL 210.8mm (8.30")
Avalign Technologies, Inc.
95-2000162064
In Commercial Distribution

  • 00190776147716 ()


  • Device sterilization/disinfection container, reusable
V-Silicone Retainers, comes w/2 screws to fasten to lid, OL 109.22mm (4.30")
Avalign Technologies, Inc.
95-2000162063
In Commercial Distribution

  • 00190776154516 ()


  • Device sterilization/disinfection container, reusable
V-Silicone Retainers, comes w/2 screws to fasten to lid, OL 109.22mm (4.30")
Avalign Technologies, Inc.
95-2000162063
In Commercial Distribution

  • 00190776150914 ()


  • Device sterilization/disinfection container, reusable
IV pole to be connected with Walking Aid to hold other medical devices
PARAMOUNT BED CO., LTD.
KC-58AU
In Commercial Distribution

  • 04527799700059 ()


  • Freestanding/bed-attached intravenous pole
TRIALTIS Spine System Double End to End Connector Closed / Closed ø5.5-6mm to 5.5-6mm
DEPUY SPINE, LLC
5560762550
In Commercial Distribution

  • 10705034645728 ()
5560762550

  • Bone-screw internal spinal fixation system connector
Instrument used to guide the implant or another instrument to the surgical site.
AJU PHARM. CO., LTD.
Fixone.I.F-G
In Commercial Distribution

  • 08800039102186 ()


  • Arthroscopic obturator
6.5 mm hex driver used to attach the connecting bolt to the implant
Curvafix Inc
CBD-001-LP
In Commercial Distribution

  • 10850070500538 ()
CBD-001-LP

  • Orthopaedic implant driver
I5 Insert to process up to 30 kidney bowls (requires Universal rack I5-2LR).
SKYTRON LLC
I5-RIKB
In Commercial Distribution

  • 10841736100582 ()
I5-RIKB

  • Surgical instrument washer/disinfector (chemical/thermal)
Cylindrical tip dedicated to drill and widen the access canal to schneiderian membrane
SATELEC
TIP TKW3 II
In Commercial Distribution

  • 03609820875330 ()
F87533

  • Dental ultrasonic surgical system handpiece tip
Cylindrical tip dedicated to drill and widen the access canal to schneiderian membrane
SATELEC
TIP TKW3
In Commercial Distribution

  • 03609820873336 ()
F87333

  • Dental ultrasonic surgical system handpiece tip
The depth gauge is used to evaluate the appropriate screw length to implant.
NEWDEAL
129134ND
Not in Commercial Distribution

  • M248129134ND1 ()
  • 10381780044802 ()


  • Surgical depth gauge, reusable
GMK Sphere Femur S1 to 7 R - Tibia S1 to 6 R tray
Medacta International SA
02.12.10.8406
In Commercial Distribution

  • 07630542723902 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
GMK Sphere Femur S1 to 7 L - Tibia S1 to 6 L tray
Medacta International SA
02.12.10.8405
In Commercial Distribution

  • 07630542723896 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
6m cable to connect PerkinElmer XRpad Detector to XRpad IPU (Interface Power Unit)
PerkinElmer Technologies GmbH & Co. KG
XRpad LPT Detector Cable 20FT-6M
In Commercial Distribution

  • 00812589020214 ()

  • Length: 6 Meter
95510929H

  • Flat panel x-ray detector integration unit
3m cable to connect PerkinElmer XRpad Detector to XRpad IPU (Interface Power Unit)
PerkinElmer Technologies GmbH & Co. KG
XRpad LPT Detector Cable 10FT-3M
In Commercial Distribution

  • 00812589020160 ()

  • Length: 3 Meter
95510931H

  • Flat panel x-ray detector integration unit
0.08" socket to snap with banana plug solder to snap, 6" lead wire
C.M.P. Canadian Medical Products Inc
W25206
In Commercial Distribution

  • B312W252060 ()


  • Transcutaneous electrical stimulation lead
Coupling to Connect sandblaster to air supply provided by Sirona dental unit tubing
DELDENT LTD.
505114
In Commercial Distribution

  • 07290016281057 ()
505114

  • Dental abrasive air jet system
Coupling to Connect sandblaster to air supply provided by Kavo dental unit tubing
DELDENT LTD.
505113
In Commercial Distribution

  • 07290016281040 ()
505113

  • Dental abrasive air jet system
Cable used to connect the CDI data module to the intended CDI device.
Terumo Cardiovascular Systems Corporation
804981
In Commercial Distribution

  • 00886799000830 ()
804981

  • Cardiopulmonary bypass system mounting unit
IVD reagent kit containing 6 tests
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0142
In Commercial Distribution

  • 00815381020321 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0143
In Commercial Distribution

  • 00815381020314 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
The intended use of this powered wheelchair is to provide mobility solutions to individuals who are limited to a seated position.
PIHSIANG MACHINERY MANUFACTURING CO., LTD.
P424LE
In Commercial Distribution

  • 04719872380078 ()


  • Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible
The intended use of this powered wheelchair is to provide mobility solutions to individuals who are limited to a seated position.
PIHSIANG MACHINERY MANUFACTURING CO., LTD.
888WNLE
In Commercial Distribution

  • 04719872380061 ()


  • Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible
The intended use of this powered wheelchair is to provide mobility solutions to individuals who are limited to a seated position.
PIHSIANG MACHINERY MANUFACTURING CO., LTD.
888WNLLHD
In Commercial Distribution

  • 04719872380054 ()


  • Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible
The intended use of this powered wheelchair is to provide mobility solutions to individuals who are limited to a seated position.
PIHSIANG MACHINERY MANUFACTURING CO., LTD.
888WNLM
In Commercial Distribution

  • 04719872380047 ()


  • Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible
The intended use of this powered wheelchair is to provide mobility solutions to individuals who are limited to a seated position.
PIHSIANG MACHINERY MANUFACTURING CO., LTD.
858WM
In Commercial Distribution

  • 04719872380030 ()


  • Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible
The intended use of this powered wheelchair is to provide mobility solutions to individuals who are limited to a seated position.
PIHSIANG MACHINERY MANUFACTURING CO., LTD.
888WA
In Commercial Distribution

  • 04719872380023 ()


  • Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible
The intended use of this powered wheelchair is to provide mobility solutions to individuals who are limited to a seated position.
PIHSIANG MACHINERY MANUFACTURING CO., LTD.
UL8WPB
In Commercial Distribution

  • 04719872380016 ()


  • Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible
The intended use of this powered wheelchair is to provide mobility solutions to individuals who are limited to a seated position.
PIHSIANG MACHINERY MANUFACTURING CO., LTD.
UL8WFE
In Commercial Distribution

  • 04719872380009 ()


  • Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible
A dental implant surgical drill used to install dental implant fixtures, used to dig a hole to guide each standard drill.
Shinhung MST Co., Ltd.
GPD5006
In Commercial Distribution

  • 08806343924544 ()


  • Fixture/appliance dental drill bit, reusable
A dental implant surgical drill used to install dental implant fixtures, used to dig a hole to guide each standard drill.
Shinhung MST Co., Ltd.
GPD5005
In Commercial Distribution

  • 08806343924537 ()


  • Fixture/appliance dental drill bit, reusable
A dental implant surgical drill used to install dental implant fixtures, used to dig a hole to guide each standard drill.
Shinhung MST Co., Ltd.
GPD5004
In Commercial Distribution

  • 08806343924520 ()


  • Fixture/appliance dental drill bit, reusable
The PiggyBack is intended to be used with guidewires to access the peripheral vasculature and to facilitate placement of interventional devices.
Vascular Solutions, Inc.
8802
Not in Commercial Distribution

  • M20688020 ()

  • Length: 145 Centimeter


  • Peripheral vascular intervention infusion catheter
The PiggyBack is intended to be used with guidewires to access the peripheral vasculature and to facilitate placement of interventional devices.
Vascular Solutions, Inc.
8801
Not in Commercial Distribution

  • M20688010 ()

  • Length: 120 Centimeter


  • Peripheral vascular intervention infusion catheter
Empty package, to enable a replacement of damaged package or a return shipment to the manufacturer (Related to ReDS Pro System)
SENSIBLE MEDICAL INNOVATIONS LTD
V2.7
In Commercial Distribution

  • 07290110070151 ()
PAK0012

  • Whole-body plethysmograph
Empty package, to enable a replacement of damaged package or a return shipment to the manufacturer (Related to ReDS Wearable System)
SENSIBLE MEDICAL INNOVATIONS LTD
V2.6
Not in Commercial Distribution

  • 07290110070106 ()
PAK0009

  • Whole-body plethysmograph
Empty package, to enable a replacement of damaged package or a return shipment to the manufacturer (Related to ReDS Wearable System)
SENSIBLE MEDICAL INNOVATIONS LTD
V2.6
Not in Commercial Distribution

  • 07290110070021 ()
PAK0009

  • Whole-body plethysmograph
PLATFORM (RE-USABLE) TO WHICH 2 ORDOCK CUPS (Not INCLUDED) ARE ATTACHED TO HOLD INSTRUMENTS DURING A SURGICAL PROCEDURE, NEEDS TO BE STERILIZED PRIOR TO USE (SEE INSTRUCTIONS FOR AUTOCLAVE)
JB Medical Development, LLC
14-100
In Commercial Distribution

  • B992141000 ()
14100

  • Surgical instrument interim-placement holder, reusable
No Description
BIOMET SPINE LLC
14-525256E
In Commercial Distribution

  • 00880304814486 ()

  • 8.0X56MM CROSS-CONNECTOR ST HEAD TO HEAD CROSS-CONNECTOR LINEUM OCT SPINE SYSTEM
14-525256E

  • Bone-screw internal spinal fixation system, sterile
No Description
BIOMET SPINE LLC
14-525249E
In Commercial Distribution

  • 00880304814479 ()

  • 8.0X49MM CROSS-CONNECTOR ST HEAD TO HEAD CROSS-CONNECTOR LINEUM OCT SPINE SYSTEM
14-525249E

  • Bone-screw internal spinal fixation system, sterile
No Description
BIOMET SPINE LLC
14-525242E
In Commercial Distribution

  • 00880304814462 ()

  • 8.0X42MM CROSS-CONNECTOR ST HEAD TO HEAD CROSS-CONNECTOR LINEUM OCT SPINE SYSTEM
14-525242E

  • Bone-screw internal spinal fixation system, sterile
No Description
BIOMET SPINE LLC
14-525235E
In Commercial Distribution

  • 00880304814455 ()

  • 8.0X35MM CROSS-CONNECTOR ST HEAD TO HEAD CROSS-CONNECTOR LINEUM OCT SPINE SYSTEM
14-525235E

  • Bone-screw internal spinal fixation system, sterile
No Description
BIOMET SPINE LLC
14-525228E
In Commercial Distribution

  • 00880304814448 ()

  • 6.5X28MM CROSS-CONNECTOR ST HEAD TO HEAD CROSS-CONNECTOR LINEUM OCT SPINE SYSTEM
14-525228E

  • Bone-screw internal spinal fixation system, sterile
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