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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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Instrument, Disc Shaver, 8mm
SPINESOURCE INC
035
In Commercial Distribution

  • 00850011324035 ()
DS-108

  • Bone-resection orthopaedic reamer, reusable
Instrument, Disc Shaver, 7mm
SPINESOURCE INC
028
In Commercial Distribution

  • 00850011324028 ()
DS-107

  • Bone-resection orthopaedic reamer, reusable
Instrument, Implant Stabilizer
SPINESOURCE INC
011
In Commercial Distribution

  • 00850011324011 ()
SP-001

  • Orthopaedic implantation sleeve, reusable
The L-Varlock is a lumbar cage, for intervertebral body fusion.
SPINESOURCE INC
004
In Commercial Distribution

  • 00850011324004 ()

  • Width: 13 Millimeter
  • Height: 8 Millimeter
VAL-CA-13-08

  • Metallic spinal fusion cage, non-sterile
This product contains a full conductive metal plated cloth inner shield with a durable plastic outer jacket which is easily applied over one or more ATLAS Tether cables providing both noise shielding and cable management.
NEURALYNX, INC.
8m
In Commercial Distribution

  • 00850011306970 ()
31-0604-0129

  • Facility radio-frequency shielding material
This product contains a full conductive metal plated cloth inner shield with a durable plastic outer jacket which is easily applied over one or more ATLAS Tether cables providing both noise shielding and cable management.
NEURALYNX, INC.
5m
In Commercial Distribution

  • 00850011306963 ()
31-0604-0128

  • Facility radio-frequency shielding material
The Ethernet Switch is a fully managed switch designed for high-performance networking in enterprise environments.
NEURALYNX, INC.
Ethernet Switch
In Commercial Distribution

  • 00850011306253 ()
31-0604-0139

  • Medical networking interface unit
The Modular Headstage-36 is a clinical headstage that connects to one of several modular electrode interfaces to connect electrodes from various manufacturers to the ATLAS Neurophysiology System. The Modular Headstage-36 uses electronic components to buffer single unit activity sensed by the electrodes and sends it to the ATLAS Data Acquisition System to be digitized.
NEURALYNX, INC.
Modular Headstage-36
In Commercial Distribution

  • 00850011306130 ()
31-0601-0091

  • Electroencephalographic signal amplifier
The HS-18-CHET-A 1.0 is a clinical headstage that allows one Ad-Tech Tail Electrode (usually consisting of up to 16 electrodes) to interface with the ATLAS Neurophysiology System.
NEURALYNX, INC.
1.0
In Commercial Distribution

  • 00850011306031 ()
HS-18-CHET-A 1.0

  • Electroencephalographic monitoring system, stationary
The HS-10-CHET-A 1.0 is a clinical headstage that allows one Ad-Tech Tail Electrode (usually consisting of up to 9 electrodes) to interface with the ATLAS Neurophysiology System.
NEURALYNX, INC.
1.0
In Commercial Distribution

  • 00850011306024 ()
HS-10-CHET-A 1.0

  • Electroencephalographic monitoring system, stationary
Style 900 Isolation Gown One Size Children National
PATIENTSTYLE MEDICAL LLC
900 ISO O/S CN
In Commercial Distribution

  • 00850011216392 ()


  • Patient gown, reusable
IV SNAP GOWN Cross Stitch Diamonds Icy Blue SIZE 3X. Cell Phone Pocket.
PATIENTSTYLE MEDICAL LLC
200P CSDB 3X
Not in Commercial Distribution

  • 00850011216019 ()
Hospital 1

  • Patient gown, reusable
IV Snap Gown O/S Cross Stitch Diamonds Icy Blue. Cell Phone Pocket. Hospital 1 Embroidery.
PATIENTSTYLE MEDICAL LLC
200P CSDB O/S
Not in Commercial Distribution

  • 00850011216002 ()


  • Patient gown, reusable
IVD RONG STR 5X10MM 11.75"
PROGRESSIVE MEDICAL INSTRUMENTATION INC
PMI-LK75-2974/09
In Commercial Distribution

  • 00850011214183 ()
PMI-LK75-2974/09

  • Orthopaedic joint/limb rongeur
IVD RONG UP 5X10MM 11.75"
PROGRESSIVE MEDICAL INSTRUMENTATION INC
PMI-LK75-2974/45
In Commercial Distribution

  • 00850011214176 ()
PMI-LK75-2974/45

  • Orthopaedic joint/limb rongeur
Grafting Instrument Kit (11 Instruments)
GoldenDent
GO GKI
In Commercial Distribution

  • 00850011211946 ()
GO GKI

  • Bone file/rasp, manual, reusable
  • Suture scissors
  • Bone curette, reusable
  • Suturing needle holder, reusable
  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
  • Periodontal knife
  • Periosteal elevator, reusable
  • Scalpel handle, reusable
  • Dappen dish, reusable
Advanced Grafting Kit (11 Instruments and Cassette)
GoldenDent
GO AGK
In Commercial Distribution

  • 00850011211939 ()
GO AGK

  • Bone file/rasp, manual, reusable
  • Instrument tray, reusable
  • Suture scissors
  • Bone curette, reusable
  • Suturing needle holder, reusable
  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
  • Periodontal knife
  • Periosteal elevator, reusable
  • Scalpel handle, reusable
  • Dappen dish, reusable
Combination Graft Spoon Packer
GoldenDent
GO SPC
In Commercial Distribution

  • 00850011211915 ()
GO SPC

  • Bone file/rasp, manual, reusable
Periosteal Elevator Molt #9
GoldenDent
GO PEL
In Commercial Distribution

  • 00850011211892 ()
GO PEL

  • Periosteal elevator, reusable
Double Ended Socket Currette
GoldenDent
GO DEC
In Commercial Distribution

  • 00850011211854 ()
GO DEC

  • Bone curette, reusable
Curved Graft Scissor
GoldenDent
GO CSM
In Commercial Distribution

  • 00850011211847 ()
GO CSM

  • Suture scissors
Grafting Cassette
GoldenDent
GO CGC
In Commercial Distribution

  • 00850011211830 ()
GO CGC

  • Instrument tray, reusable
Bone File #10
GoldenDent
GO BFI
In Commercial Distribution

  • 00850011211823 ()
GO BFI

  • Bone file/rasp, manual, reusable
ORFIT MRI-S Solution Head, Neck & Shoulders
Orfit Industries NV
29102
In Commercial Distribution

  • 05420028755020 ()


  • DNA-based tissue typing IVD, reagent
Set of 3 RD Head supports without Lateral neck Flaps
Orfit Industries NV
32706-MD
In Commercial Distribution

  • 05420028754757 ()


  • DNA-based tissue typing IVD, reagent
Set of 3 Head Supports Regular Density with lateral neck flaps
Orfit Industries NV
32701-MD
In Commercial Distribution

  • 05420028754740 ()


  • DNA-based tissue typing IVD, reagent
RD Head Support Extra Soft - Model6 Without Lateral Neck Flaps
Orfit Industries NV
32432
In Commercial Distribution

  • 05420028754665 ()


  • DNA-based tissue typing IVD, reagent
RD Head Support Extra Soft - Model5 With Lateral Neck Flaps
Orfit Industries NV
32431
In Commercial Distribution

  • 05420028754658 ()


  • DNA-based tissue typing IVD, reagent
RD Head Support Extra Soft - Model4 Without Lateral Neck Flaps
Orfit Industries NV
32430
In Commercial Distribution

  • 05420028754641 ()


  • DNA-based tissue typing IVD, reagent
RD Head Support Extra Soft - Model3 With Lateral Neck Flaps
Orfit Industries NV
32429
In Commercial Distribution

  • 05420028754634 ()


  • DNA-based tissue typing IVD, reagent
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