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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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g.Nautilus PRO - EBCI5112PRO0

The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
16-Channel-rX
In Commercial Distribution

  • EBCI5112PRO0 ()

  • Channel Number 16
5112PRO

  • Multiple physiological signal amplifier

g.Nautilus PRO - EBCI5111PRO0

The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
16-Channel-mB
In Commercial Distribution

  • EBCI5111PRO0 ()

  • Channel Number 16
5111PRO

  • Multiple physiological signal amplifier

g.Nautilus PRO - EBCI5110PRO0

The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
16-Channel
In Commercial Distribution

  • EBCI5110PRO0 ()

  • Channel Number 16
5110PRO

  • Multiple physiological signal amplifier

g.Nautilus PRO - EBCI5101PRO0

The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
32-Channel-CSP
In Commercial Distribution

  • EBCI5101PRO0 ()

  • Channel Number 32
5101PRO

  • Multiple physiological signal amplifier

g.Nautilus PRO - EBCI5100PRO0

The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
32-Channel
In Commercial Distribution

  • EBCI5100PRO0 ()

  • Channel Number 32
5100PRO

  • Multiple physiological signal amplifier

g.USBamp - EBCI0216US0

The g.USBamp is inteded to measuring, recording and analysis of electrical activity of the brain (EEG) and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for the EEG.
g.tec medical engineering GmbH
USB Biosignal Amplifier
Not in Commercial Distribution


  • Channel Number 16
0216US

  • Multiple physiological signal amplifier

g.USBamp - EBCI02160

The g.USBamp is inteded to measuring, recording and analysis of electrical activity of the brain (EEG) and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for the EEG.
g.tec medical engineering GmbH
USB Biosignal Amplifier
Not in Commercial Distribution

  • EBCI02160 ()

  • Channel Number 16
0216

  • Multiple physiological signal amplifier

Scanlan® SURG-I-LOOP® silicone loops - 00846159027761

Scanlan® SURG-I-LOOP® silicone loops - Yellow Mini, 1.5x.88 mm, 16"/40 cm long, Bulk Non-Sterile (20/pkg)
SCANLAN INTERNATIONAL INC
1001-79B
In Commercial Distribution

  • 00846159027761 ()
1001-79B

  • Surgical vessel loop

Scanlan® SURG-I-LOOP® silicone loops - 00846159027730

Scanlan® SURG-I-LOOP® silicone loops - Blue Mini, 1.5x.88 mm, 16"/40 cm long, Bulk Non-Sterile (20/pkg)
SCANLAN INTERNATIONAL INC
1001-77B
In Commercial Distribution

  • 00846159027730 ()
1001-77B

  • Surgical vessel loop

Scanlan® SURG-I-LOOP® silicone loops - 00846159027716

Scanlan® SURG-I-LOOP® silicone loops - Red Mini, 1.5x.88 mm, 16"/40 cm long, Bulk Non-Sterile (20/pkg)
SCANLAN INTERNATIONAL INC
1001-75B
In Commercial Distribution

  • 00846159027716 ()
1001-75B

  • Surgical vessel loop

Sound Body - 00017276236484

Antibacterial Waterproof Adhesive Bandages, all one size 2 IN x 3 1/2 IN (50 mm x 88 mm)
Aso LLC
017276236484
In Commercial Distribution

  • 20017276236488 ()
  • 00017276236484 ()
  • 60017276236486 ()


  • Skin-cover adhesive strip, antimicrobial

K-Z Z-TURN - 00817012023176

ZMatt intellimatt, Alternating Rotation, with True Low Air Loss, Expandable Mattress system 36"~39"/42"~48", 80"~84"~88",
KAP MEDICAL
K-ZZMXMS
In Commercial Distribution

  • 00817012023176 ()
K-ZZMXMS

  • Low-air-loss bed

K-4oem AIRE-FLOAT - 00817012021561

Alternating Pressure with Low Air Loss Expandable Mattress System, 80"-84"-88" x 36"-39"-42"-48" x 10"
KAP MEDICAL
K-4oemXMS
In Commercial Distribution

  • 00817012021561 ()
K-4oemXMS

  • Low-air-loss bed

ICU Medical - 00887709014961

88" (224 cm) 60 Drop, 150 ml Burette Set (MicroClave®, Shut Off) w/2 Clave®, Rotating Luer
ICU MEDICAL, INC.
B9720
In Commercial Distribution

  • 10887709014968 ()
  • 00887709014961 ()


  • Basic intravenous administration set, noninvasive

Trinity Biotech - 05391516749169

HEp-2 WB IgG Positive Control, 250 µL
MARDX DIAGNOSTICS, INC.
40-3022L
In Commercial Distribution

  • 05391516749169 ()
40-3022L

  • Multiple extractable nuclear antigen (ENA) IVD, control

AUTO I.D.® Sm/RNP Autoantibody Test System - M7490605011

AUTO I.D.® Universal Antigen - 1 x 0.2 ml
IMMUNO CONCEPTS INC
6050 (1)
In Commercial Distribution

  • M7490605011 ()
6050 (1)

  • Multiple extractable nuclear antigen (ENA) IVD, control

Urine Calibrator Set - 04250317551115

3PLUS1® Multilevel Urine Calibrator Set MassChrom® Amino Acid Analysis in urine
Chromsystems Instruments + Chemicals GmbH
75228
In Commercial Distribution

  • 04250317551115 ()

  • Total Volume: 0.5 Milliliter
  • 4 vials
75228

  • Multiple amino acid IVD, calibrator

Plasma Calibrator Set - 04250317548221

3PLUS1® Multilevel Plasma Calibrator Set MassChrom® Amino Acid Analysis in plasma/serum
Chromsystems Instruments + Chemicals GmbH
75128
In Commercial Distribution

  • 04250317548221 ()

  • Total Volume: 0.5 Milliliter
  • 4 vials
75128

  • Multiple amino acid IVD, calibrator

ABX PENTRA CK CONTROL - 03610230005545

No Description
HORIBA ABX SAS
1220001786
Not in Commercial Distribution

  • 03610230005545 ()


  • Creatine kinase (CK) multiple isoenzyme IVD, control

JAS Diagnostics - 00817274020906

AST LIQUID REAGENT (5 x 40 mL)
DREW SCIENTIFIC, INC.
XL-AST2-40
In Commercial Distribution

  • 00817274020906 ()


  • Aspartate aminotransferase (AST) isoenzyme IVD, control

JAS Diagnostics - 00817274020883

AST LIQUID REAGENT (125mL) Unlabeld Vial
DREW SCIENTIFIC, INC.
AST2-125U
In Commercial Distribution

  • 00817274020883 ()


  • Aspartate aminotransferase (AST) isoenzyme IVD, control

JAS Diagnostics - 00817274020869

AST LIQUID (2x 125mL)
DREW SCIENTIFIC, INC.
AST2-125
In Commercial Distribution

  • 00817274020869 ()


  • Aspartate aminotransferase (AST) isoenzyme IVD, control

JAS Diagnostics - 00817274020685

ALP LIQUID (1x 120mL R1, 1x 30mL R2)
DREW SCIENTIFIC, INC.
ALP2-120
In Commercial Distribution

  • 00817274020685 ()


  • Creatine kinase (CK) multiple isoenzyme IVD, control

JAS Diagnostics - 00817274020913

AST PALS BULK (in 20 dry Liter bottles)
DREW SCIENTIFIC, INC.
AST2-BUP
In Commercial Distribution

  • 00817274020913 ()


  • Aspartate aminotransferase (AST) isoenzyme IVD, control

JAS Diagnostics - 00817274020890

AST LIQUID REAGENT (1x 1L)
DREW SCIENTIFIC, INC.
AST2-1L
In Commercial Distribution

  • 00817274020890 ()


  • Aspartate aminotransferase (AST) isoenzyme IVD, control

JAS Diagnostics - 00817274020876

AST LIQUID BULK (sold in 20L cub)
DREW SCIENTIFIC, INC.
AST2-BUL
In Commercial Distribution

  • 00817274020876 ()


  • Aspartate aminotransferase (AST) isoenzyme IVD, control

JAS Diagnostics - 00817274020852

AST LIQUID (1x 125mL)
DREW SCIENTIFIC, INC.
DG-AST2-125A
In Commercial Distribution

  • 00817274020852 ()


  • Aspartate aminotransferase (AST) isoenzyme IVD, control

FSSB - 00848782042562

2xGLZ-16.0-150 USP 9-0 Polypropylene blue 10 cm. sterile VA1
Surgical Specialties México, S. de R.L. de C.V.
A062PP
In Commercial Distribution

  • 10848782042569 ()
  • 00848782042562 ()

  • 9-0 USP
A062PP

  • Polyolefin/fluoropolymer suture, monofilament

2hsl5 9-0 Bk Mono Nyl 12"/30cm - 00848782010721

2hsl5 9-0 Bk Mono Nyl 12"/30cm
Surgical Specialties México, S. de R.L. de C.V.
A7760N
In Commercial Distribution

  • 10848782010728 ()
  • 00848782010721 ()

  • 9-0 USP
A7760

  • Nylon suture, non-bioabsorbable, monofilament

2dsl7 9-0 Bk Mono Nyl 12"/30cm - 00848782010684

2dsl7 9-0 Bk Mono Nyl 12"/30cm
Surgical Specialties México, S. de R.L. de C.V.
A7717N
In Commercial Distribution

  • 10848782010681 ()
  • 00848782010684 ()

  • 9-0 USP
A7717

  • Nylon suture, non-bioabsorbable, monofilament

Hsl5 9-0 Bk Mono Nyl 6"/15cm - 00848782010332

Hsl5 9-0 Bk Mono Nyl 6"/15cm
Surgical Specialties México, S. de R.L. de C.V.
A2681N
In Commercial Distribution

  • 10848782010339 ()
  • 00848782010332 ()

  • 9-0 USP
A2681

  • Nylon suture, non-bioabsorbable, monofilament

Vvl4 9-0 Bk Mono Nyl 5"/13cm - 00848782009893

Vvl4 9-0 Bk Mono Nyl 5"/13cm
Surgical Specialties México, S. de R.L. de C.V.
A0819N
In Commercial Distribution

  • 10848782009890 ()
  • 00848782009893 ()

  • 9-0 USP
A0819

  • Nylon suture, non-bioabsorbable, monofilament

2hgl5 9-0 Bl Ppn 6"/15 Cm - 00848782017188

2hgl5 9-0 Bl Ppn 6"/15 Cm
Surgical Specialties México, S. de R.L. de C.V.
JA-2625N
In Commercial Distribution

  • 10848782017185 ()
  • 00848782017188 ()

  • 9-0 USP
JA-2625

  • Polyolefin/fluoropolymer suture, monofilament

Drm5 9-0 Bl Ppn 5"/13 Cm - 00848782016990

Drm5 9-0 Bl Ppn 5"/13 Cm
Surgical Specialties México, S. de R.L. de C.V.
JA-2123N
In Commercial Distribution

  • 10848782016997 ()
  • 00848782016990 ()

  • 9-0 USP
JA-2123

  • Polyolefin/fluoropolymer suture, monofilament

Vvl4 9-0 Bk Mono Nyl 5"/13cm - 00848782011575

Vvl4 9-0 Bk Mono Nyl 5"/13cm
Surgical Specialties México, S. de R.L. de C.V.
AA-2819N
In Commercial Distribution

  • 10848782011572 ()
  • 00848782011575 ()

  • 9-0 USP
AA-2819

  • Nylon suture, non-bioabsorbable, monofilament

Hsl5 9-0 Bk Mono Nyl 6"/15 Cm - 00848782011506

Hsl5 9-0 Bk Mono Nyl 6"/15 Cm
Surgical Specialties México, S. de R.L. de C.V.
AA-2681N
In Commercial Distribution

  • 10848782011503 ()
  • 00848782011506 ()

  • 9-0 USP
AA-2681

  • Nylon suture, non-bioabsorbable, monofilament

Drm4 9-0 Bk Mono Nyl 5"/13 Cm - 00848782011438

Drm4 9-0 Bk Mono Nyl 5"/13 Cm
Surgical Specialties México, S. de R.L. de C.V.
AA-2586
In Commercial Distribution

  • 10848782011435 ()
  • 00848782011438 ()

  • 9-0 USP


  • Nylon suture, non-bioabsorbable, monofilament

2hsv6 9-0 Bk Mono Nyl 1"/2.5cm - 00848782011414

2hsv6 9-0 Bk Mono Nyl 1"/2.5cm
Surgical Specialties México, S. de R.L. de C.V.
AA-2545
In Commercial Distribution

  • 10848782011411 ()
  • 00848782011414 ()

  • 9-0 USP


  • Nylon suture, non-bioabsorbable, monofilament

2drm5 9-0 Bk Mono Nyl 1"/2.5cm - 00848782011407

2drm5 9-0 Bk Mono Nyl 1"/2.5cm
Surgical Specialties México, S. de R.L. de C.V.
AA-2544
In Commercial Distribution

  • 10848782011404 ()
  • 00848782011407 ()

  • 9-0 USP


  • Nylon suture, non-bioabsorbable, monofilament

2dsl7 9-0 Bk Mono Nyl 12"/30cm - 00848782011292

2dsl7 9-0 Bk Mono Nyl 12"/30cm
Surgical Specialties México, S. de R.L. de C.V.
AA-2517N
In Commercial Distribution

  • 10848782011299 ()
  • 00848782011292 ()

  • 9-0 USP
AA-2517

  • Nylon suture, non-bioabsorbable, monofilament

Hsv6 9-0 Bk Mono Nyl 5"/13 Cm - 00848782011117

Hsv6 9-0 Bk Mono Nyl 5"/13 Cm
Surgical Specialties México, S. de R.L. de C.V.
AA-1825
In Commercial Distribution

  • 10848782011114 ()
  • 00848782011117 ()

  • 9-0 USP


  • Nylon suture, non-bioabsorbable, monofilament

Dr5 9-0 Bk Mono Nyl 5"/13 Cm - 00848782011049

Dr5 9-0 Bk Mono Nyl 5"/13 Cm
Surgical Specialties México, S. de R.L. de C.V.
AA-0142
In Commercial Distribution

  • 10848782011046 ()
  • 00848782011049 ()

  • 9-0 USP


  • Nylon suture, non-bioabsorbable, monofilament

Vr5 9-0 Bk Mono Nyl 5"/13 Cm - 00848782011018

Vr5 9-0 Bk Mono Nyl 5"/13 Cm
Surgical Specialties México, S. de R.L. de C.V.
AA-0137
In Commercial Distribution

  • 10848782011015 ()
  • 00848782011018 ()

  • 9-0 USP


  • Nylon suture, non-bioabsorbable, monofilament

Drm6 9-0 Bk Mono Nyl 5"/13 Cm - 00848782010967

Drm6 9-0 Bk Mono Nyl 5"/13 Cm
Surgical Specialties México, S. de R.L. de C.V.
AA-0121
In Commercial Distribution

  • 10848782010964 ()
  • 00848782010967 ()

  • 9-0 USP


  • Nylon suture, non-bioabsorbable, monofilament

Vrm6 9-0 Bk Mono Nyl 5"/13 Cm - 00848782010950

Vrm6 9-0 Bk Mono Nyl 5"/13 Cm
Surgical Specialties México, S. de R.L. de C.V.
AA-0116
In Commercial Distribution

  • 10848782010957 ()
  • 00848782010950 ()

  • 9-0 USP


  • Nylon suture, non-bioabsorbable, monofilament

Drm5 9-0 Bk Mono Nyl 5"/13 Cm - 00848782010943

Drm5 9-0 Bk Mono Nyl 5"/13 Cm
Surgical Specialties México, S. de R.L. de C.V.
AA-0112
In Commercial Distribution

  • 10848782010940 ()
  • 00848782010943 ()

  • 9-0 USP


  • Nylon suture, non-bioabsorbable, monofilament

Hrm4 9-0 Bk Mono Nyl 5"/13 Cm - 00848782010912

Hrm4 9-0 Bk Mono Nyl 5"/13 Cm
Surgical Specialties México, S. de R.L. de C.V.
AA-0105
In Commercial Distribution

  • 10848782010919 ()
  • 00848782010912 ()

  • 9-0 USP


  • Nylon suture, non-bioabsorbable, monofilament

Onatec - 00848782040360

Onalene Polypropylene blue 9-0 10CM 1-4 Circle 1 arm
Surgical Specialties México, S. de R.L. de C.V.
OE461981
In Commercial Distribution

  • 10848782040367 ()
  • 00848782040360 ()

  • 9-0 USP
OE461981

  • Polyolefin/fluoropolymer suture, monofilament

Onatec - 00848782040346

Onalene Polypropylene blue 9-0, 10cm, Straight, 1 arm
Surgical Specialties México, S. de R.L. de C.V.
OE172081
In Commercial Distribution

  • 10848782040343 ()
  • 00848782040346 ()

  • 9-0 USP
OE172081

  • Polyolefin/fluoropolymer suture, monofilament

Disc Prep - 10889981104009

Probe-90 Deg Ball Long
Seaspine Orthopedics Corporation
06-50-0036
In Commercial Distribution

  • 10889981104009 ()

  • 90 Deg
06-50-0036

  • Neurosurgical probe
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