Company Name Brand Name GMDN Term 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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Surgical Smoke Evacuator
Buffalo Filter
PPS604
In Commercial Distribution

  • 00851136002044 ()


  • Surgical plume evacuation system
Premier Evacuator 110V Air Filtration System. Contains one Premier Evacuator 110V unit, one detachable cord, and Disposable Filter Pack (5 filters - reorder number 9006290).
DERMATOLOGIC LAB AND SUPPLY, INC.
9006300
In Commercial Distribution

  • D69190063000 ()
9006300

  • Surgical plume evacuation system
Premier Evacuator 220V Air Filtration System. Contains one Premier Evacuator 220V unit, one detachable cord, and Disposable Filter Pack (5 filters - reorder number 9006290).
DERMATOLOGIC LAB AND SUPPLY, INC.
9006298
In Commercial Distribution

  • D69190062980 ()
9006298

  • Surgical plume evacuation system
Premier Filter Pack for Premier Evacuator. Contains five disposable Premier filters.
DERMATOLOGIC LAB AND SUPPLY, INC.
9006290
In Commercial Distribution

  • D69190062901 ()
  • D69190062900 ()
9006290

  • Surgical plume evacuation system
Tecapro mt.
Innovasis, Inc.
LS-215
In Commercial Distribution

  • M711LS2150 ()
LS-215

  • Bone graft packing block
No Description
QIAGEN GmbH
V1
In Commercial Distribution

  • 04053228033905 ()
691221

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
QUIKLINK Automatic Activation Device for SMOKE-E-VAC Smoke Plume Evacuator
Conmed Corporation
QUIKLINK
In Commercial Distribution

  • 30845854061231 ()
QUIKLINK

  • Surgical plume evacuation system
Gamma Camera System
Ddd-Diagnostic A/S
QuantumCam Gamma Camera System
In Commercial Distribution

  • 05711665003033 ()

  • Weight: 2144 Kilogram
  • Height: 225 Centimeter
  • Depth: 197 Centimeter
  • Width: 291 Centimeter
9SYS2070

  • Stationary gamma camera system
Gamma Camera System
Ddd-Diagnostic A/S
QuantumCam Gamma Camera System
In Commercial Distribution

  • 05711665003002 ()

  • Weight: 2144 Kilogram
  • Height: 225 Centimeter
  • Depth: 197 Centimeter
  • Width: 291 Centimeter
9SYS2070

  • Stationary gamma camera system
No Description
I.C. MEDICAL, INC.
ICM-000-0546
In Commercial Distribution

  • 00817688021759 ()


  • Surgical plume evacuation system
No Description
I.C. MEDICAL, INC.
ICM-000-0561
In Commercial Distribution

  • 00817688022411 ()


  • Surgical plume evacuation system
Compactor
SpineArt SA
PAD-IN 05 00-N
In Commercial Distribution

  • 07640139349309 ()
PAD-IN 05 00-N

  • Bone graft packing block
Compaction Base
SpineArt SA
PAD-IN 04 00-N
In Commercial Distribution

  • 07640139349293 ()
PAD-IN 04 00-N

  • Bone graft packing block
Smoke Evacuator,220-240 V, 50/60 Hz; 8 Amps
Covidien LP
SE3695
In Commercial Distribution

  • 10884524001753 ()
SE3695

  • Surgical plume evacuation system
Smoke Evacuator,100-120 V, 50/60 Hz; 10 Amps
Covidien LP
SE3690
In Commercial Distribution

  • 10884524001555 ()
SE3690

  • Surgical plume evacuation system
Smoke Evacuator 110V
Covidien LP
SE3690ZD
In Commercial Distribution

  • 10884521134140 ()
SE3690ZD

  • Surgical plume evacuation system
The device is a lightweight, wearable, battery-powered soft orthotic exosuit intended to be used to preform ambulatory functions in rehabilitation institutions under the supervision of a trained therapist for people with hemiplegia / hemiparesis due to stroke.
REWALK ROBOTICS LTD
50-40-0001
In Commercial Distribution

  • 00860001744507 ()


  • Programmable ambulation exoskeleton, clinical
Powered Exoskeleton - rehabilitation institution use
REWALK ROBOTICS LTD
50-30-0001
In Commercial Distribution

  • 00861803000327 ()


  • Programmable ambulation exoskeleton, clinical
RC R-MIX TOO SV FROZEN
DIAGNOSTIC HYBRIDS, INC.
F-97-0102-24
In Commercial Distribution

  • 30014613335849 ()
F-97-0102-24

  • Cell culture line IVD
RC R-MIX SV FROZEN CULT
DIAGNOSTIC HYBRIDS, INC.
F-96-0102-24
In Commercial Distribution

  • 30014613335832 ()
F-96-0102-24

  • Cell culture line IVD
SUPER E-MIX READYCELLS-24 VIAL
DIAGNOSTIC HYBRIDS, INC.
F-92-0102-24
In Commercial Distribution

  • 30014613335825 ()
F-92-0102-24

  • Cell culture line IVD
RC HS27 SV FROZEN CULT
DIAGNOSTIC HYBRIDS, INC.
F-87-0102-24
In Commercial Distribution

  • 30014613335818 ()
F-87-0102-24

  • Cell culture line IVD
RC MCCOY SV FROZEN CULT
DIAGNOSTIC HYBRIDS, INC.
F-54-0102-24
In Commercial Distribution

  • 30014613335801 ()
F-54-0102-24

  • Cell culture line IVD
Graft Block
SEASPINE ORTHOPEDICS CORPORATION
TA2-006000
In Commercial Distribution

  • 10889981213022 ()
TA2-006000

  • Bone graft packing block
Graft Block
SEASPINE ORTHOPEDICS CORPORATION
TO2-006000
In Commercial Distribution

  • 10889981195755 ()
TO2-006000

  • Bone graft packing block
Graft Block
SEASPINE ORTHOPEDICS CORPORATION
36-90-3061
In Commercial Distribution

  • 10889981162368 ()
36-90-3061

  • Bone graft packing block
The ReoAmbulator model is robotics-based powered exercise equipment intended to redevelop muscles and to restore motion to joints during the rehabilitation of a patient recovering from a stroke or other neuromuscular condition. The ReoAmbulator enables passive and allows active motions of the lower limbs, which are carried out by a single robotic guide. The robotic guide is modular, and designed to be appropriate for use both in the in-patient and outpatient facilities. It incorporates sensors for accurate motion control of the robotic guide and provides measures of patient performance.
MOTORIKA MEDICAL (ISRAEL) LTD
B
In Commercial Distribution

  • 07290017844305 ()
RA01-0000-00

  • Gait rehabilitation system harness
SABER LUMBAR I/F CAGE SYSTEM BONE PACKING STAND
DEPUY SPINE, LLC
287006000
Not in Commercial Distribution

  • 10705034215716 ()
287006000

  • Bone graft packing block
No Description
EDGE SYSTEMS LLC
10000
In Commercial Distribution

  • 00850043007067 ()
10000

  • Surgical plume evacuation system
Bone Packing Mold Base
K2M, INC.
1708-90043
In Commercial Distribution

  • 10888857023581 ()
1708-90043

  • Bone graft packing block
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