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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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Heparin Lock Flush Syringe 10 Units/mL - 30364253222239

Medefil Heparin Lock Flush Syringe, 10 Units/mL, 3mL fill in 6mL syringe, Does not contain natural rubber latex or preservatives, Contents and its pathway are sterile, Single Use
MEDEFIL, INC.
3mL in 6mL syringe
In Commercial Distribution

  • 30364253222239 ()
  • 10364253222235 ()
  • 50364253222233 ()
MIH-2223

  • Vascular catheter/cannula flush solution, anticoagulant, non-antimicrobial

Medefil Heparin Lock Flush Syringe, 10 Unit/mL - 30364253222222

Medefil Heparin Lock Flush Syringe, 10 Unit/mL, 2mL in 6mL Syringe, Does not contain natural rubber latex or preservatives. Contents and its pathway are sterile. Single use.
MEDEFIL, INC.
2mL in 6mL Syringe
In Commercial Distribution

  • 50364253222226 ()
  • 30364253222222 ()
  • 10364253222228 ()
MIH-2222

  • Vascular catheter/cannula flush solution, anticoagulant, non-antimicrobial

Normal Saline IV Flush Syringe - 30364253111335

Medefil Normal Saline IV Flush Syringe, 3mL fill in 12mL syringe, Does not contain natural rubber latex or preservatives, Contents and its pathway are sterile, Single Use
MEDEFIL, INC.
3mL in 12mL Syringe
In Commercial Distribution

  • 30364253111335 ()
  • 10364253111331 ()
  • 50364253111339 ()
MIS-1133

  • Vascular catheter flush syringe

Normal Saline IV Flush Syringe - 30364253111304

Medefil Normal Saline IV Flush Syringe, 10mL fill in 12mL syringe, Does not contain natural rubber latex or preservatives, Contents and its pathway are sterile, Single Use
MEDEFIL, INC.
10mL in 12mL syringe
In Commercial Distribution

  • 30364253111304 ()
  • 10364253111300 ()
  • 50364253000305 ()
MIS-1130

  • Vascular catheter flush syringe

Normal Saline IV Flush Syringe - 30364253111250

Medefil Normal Saline IV Flush Syringe, 5mL fill in 6mL syringe, Does not contain natural rubber latex or preservatives, Contents and its pathway are sterile, Single Use
MEDEFIL, INC.
5mL in 6mL Syringe
In Commercial Distribution

  • 30364253111250 ()
  • 10364253111256 ()
  • 50364253111254 ()
MIS-1125

  • Vascular catheter flush syringe

Normal Saline IV Flush Syringe - 30364253111236

Medefil Normal Saline IV Flush Syringe, 3mL fill in 6mL syringe, Does not contain natural rubber latex or preservatives, Contents and its pathway are sterile, Single Use
MEDEFIL, INC.
3mL in 6mL Syringe
In Commercial Distribution

  • 30364253111236 ()
  • 10364253111232 ()
  • 50364253111230 ()
MIS-1123

  • Vascular catheter flush syringe

Normal Saline IV Flush Syringe - 30364253111229

Medefil Normal Saline IV Flush Syringe, 2mL in 6mL Syringe, Does not contain natural rubber latex or preservatives. Contents and its pathway are sterile. Single Use.
MEDEFIL, INC.
2mL in 6mL Syringe
In Commercial Distribution

  • 50364253111223 ()
  • 30364253111229 ()
  • 10364253111225 ()
MIS-1122

  • Vascular catheter flush syringe

Normnal Saline I.V. Flush Syringe - 30364253111212

Medefil Normal Saline IV Flush Syringe, 1mL in 6mL syringe, does not contain natural latex rubber or preservatives, contents and its pathway are sterile. Single Use.
MEDEFIL, INC.
1mL in 6mL Syringe
In Commercial Distribution

  • 50364253111216 ()
  • 30364253111212 ()
  • 10364253111218 ()
MIS-1121

  • Vascular catheter flush syringe

Lucky Super Soft - 00808829127065

First Aid Bandages Wihout Drug (With no drug, Adhesive bandages in a variety of different sizes and shapes )Identification. A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
DELTA BRANDS INC.
Bandages in differenet size
In Commercial Distribution

  • 00808829127065 ()


  • Skin-cover adhesive strip, non-antimicrobial

Lucky Super Soft - 00808829124170

First Aid Bandages Wihout Drug (With no drug, Adhesive bandages in a variety of different sizes and shapes )Identification. A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
DELTA BRANDS INC.
Bandages In Different Size
In Commercial Distribution

  • 00808829124170 ()


  • Skin-cover adhesive strip, non-antimicrobial

Lucky Super Soft - 00808829120325

First Aid Bandages Wihout Drug (With no drug, Adhesive bandages in a variety of different sizes and shapes )Identification. A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
DELTA BRANDS INC.
Bandages in different sizes
In Commercial Distribution

  • 00808829120325 ()


  • Skin-cover adhesive strip, non-antimicrobial

Lucky Super Soft - 00808829119695

First Aid Bandages Wihout Drug (With no drug, Adhesive bandages in a variety of different sizes and shapes )Identification. A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
DELTA BRANDS INC.
Bandages in differenet size
In Commercial Distribution

  • 00808829119695 ()


  • Skin-cover adhesive strip, non-antimicrobial

Lucky Super Soft - 00808829041002

First Aid Bandages Wihout Drug (With no drug, Adhesive bandages in a variety of different sizes and shapes )Identification. A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
DELTA BRANDS INC.
Bandages in differenet size
In Commercial Distribution

  • 00808829041002 ()


  • Skin-cover adhesive strip, non-antimicrobial

Signature Care - 00321130148104

Sheer Adhesive Bandages, assorted, 3/4 IN x 3 IN (19 mm x 76 mm), 2 1/4 IN x 3 IN (57 mm x 76 mm), 5/8 IN x 2 1/4 IN (15 mm x 57 mm) 7/8 IN x 7/8 IN (22 mm x 22 mm)
BETTER LIVING BRANDS LLC
321130148104
In Commercial Distribution

  • 10321130148101 ()
  • 00321130148104 ()
  • 60321130148106 ()


  • Skin-cover adhesive strip, non-antimicrobial

ATLAS COMBO BOARD - 00850011306147

The ATLAS Combo Board combines the functionality of the ATLAS Hybrid Input Board and ATLAS DRS-36 Board onto a single board, meaning the Digital Reference Selection and Analog to Digital Conversion for 32 electrodes is combined into a single slot.
NEURALYNX, INC.
ATLAS COMBO BOARD
In Commercial Distribution

  • 00850011306147 ()
31-0605-0117

  • Electroencephalographic monitoring system

McKesson - 00612479141285

Pinwheel, Wartenberg 7.5 in
MCKESSON MEDICAL-SURGICAL INC.
43-1-029
In Commercial Distribution

  • 00612479141285 ()


  • Pinwheel aesthesiometer

A. Titan Instruments - 00841685111823

Burnisher 2-27 in #22
A. TITAN INSTRUMENTS, INC.
2-27 22
In Commercial Distribution

  • 00841685111823 ()


  • Manual dental burnisher, reusable

Creation Willi Geller - 09010782022108

In Nova Neo Fluid
KLEMA Dentalprodukte GmbH
001163
In Commercial Distribution

  • 09010782022108 ()
001163

  • Dental appliance fabrication material, ceramic

Creation Willi Geller - 09010782003114

In Nova Neo Kit
KLEMA Dentalprodukte GmbH
001150
In Commercial Distribution

  • 09010782003114 ()
001150

  • Dental appliance fabrication material, ceramic

Arsenal - 00844856070134

IN SITU BENDER RIGHT
ALPHATEC SPINE, INC.
87061
In Commercial Distribution

  • 00844856070134 ()


  • Manual orthopaedic bender, reusable

Arsenal - 00844856070127

IN SITU BENDER LEFT
ALPHATEC SPINE, INC.
87060
In Commercial Distribution

  • 00844856070127 ()


  • Manual orthopaedic bender, reusable

A.L.P.S. mvX™ - 00196449016402

1.1MM K-WIRE 6 IN
Tyber Medical LLC
770900103
In Commercial Distribution

  • 00196449016402 ()
770900103

  • Orthopaedic guidewire, single-use

A.L.P.S. mvX™ - 00196449010158

0.9MM K-WIRE 6 IN
Tyber Medical LLC
770018090
In Commercial Distribution

  • 00196449010158 ()
770018090

  • Orthopaedic guidewire, single-use

A.L.P.S. mvX™ - 00196449010141

1.6MM K-WIRE 6 IN
Tyber Medical LLC
770018160
In Commercial Distribution

  • 00196449010141 ()
770018160

  • Orthopaedic guidewire, single-use

NAR Kit - 00842209103232

KIT, IFAK - CAT IN
NORTH AMERICAN RESCUE, LLC
85-1377
In Commercial Distribution

  • 00842209103232 ()
85-1377

  • First aid kit, non-medicated, single-use

Zavation - 00842166178908

In Situ Rod Bender
Zavation LLC
10-1019
In Commercial Distribution

  • 00842166178908 ()


  • Manual orthopaedic bender, reusable

Disc Prep - 10889981102760

Pituitary-10 IN. Down 5mm
Seaspine Orthopedics Corporation
06-35-0225
In Commercial Distribution

  • 10889981102760 ()

  • 5mm
06-35-0225

  • Spinal rongeur

Disc Prep - 10889981102753

Pituitary-10 IN. Down 3mm
Seaspine Orthopedics Corporation
06-35-0223
In Commercial Distribution

  • 10889981102753 ()

  • 3mm
06-35-0223

  • Spinal rongeur

Disc Prep - 10889981102722

Pituitary-10 IN. Toothed 5mm
Seaspine Orthopedics Corporation
06-35-0205
In Commercial Distribution

  • 10889981102722 ()

  • 5mm
06-35-0205

  • Spinal rongeur

Disc Prep - 10889981102715

Pituitary-10 IN. Toothed 3mm
Seaspine Orthopedics Corporation
06-35-0203
In Commercial Distribution

  • 10889981102715 ()

  • 3mm
06-35-0203

  • Spinal rongeur

Unimed - 06936735487059

Adult (Color:All in blue)
Unimed Medical Supplies, Inc.
UU-SE-A-N
In Commercial Distribution

  • 06936735487059 ()


  • Electrical-only medical device connection cable, reusable

DENALI Spinal System - 10888857009905

In Situ Bender (Right)
K2M, INC.
101-90080
In Commercial Distribution

  • 10888857009905 ()
101-90080

  • Orthopaedic prosthesis implantation positioning instrument, reusable

DENALI Spinal System - 10888857009899

In Situ Bender (Left)
K2M, INC.
101-90079
In Commercial Distribution

  • 10888857009899 ()
101-90079

  • Orthopaedic prosthesis implantation positioning instrument, reusable

DENALI Spinal System - 10888857009639

In Situ Bender (Right)
K2M, INC.
101-90030
In Commercial Distribution

  • 10888857009639 ()
101-90030

  • Orthopaedic prosthesis implantation positioning instrument, reusable

DENALI Spinal System - 10888857009622

In Situ Bender (Left)
K2M, INC.
101-90029
In Commercial Distribution

  • 10888857009622 ()
101-90029

  • Orthopaedic prosthesis implantation positioning instrument, reusable

CASPIAN Spinal System - 10888857016873

In Situ Bender (Right)
K2M, INC.
1101-90034
In Commercial Distribution

  • 10888857016873 ()
1101-90034

  • Orthopaedic prosthesis implantation positioning instrument, reusable

CASPIAN Spinal System - 10888857016866

In Situ Bender (Left)
K2M, INC.
1101-90033
In Commercial Distribution

  • 10888857016866 ()
1101-90033

  • Orthopaedic prosthesis implantation positioning instrument, reusable

MESA Small Stature Spinal System - 10888857052857

In Situ Bender (Right)
K2M, INC.
3001-90079
In Commercial Distribution

  • 10888857052857 ()
3001-90079

  • Manual orthopaedic bender, reusable

MESA Small Stature Spinal System - 10888857052840

In Situ Bender (Left)
K2M, INC.
3001-90078
In Commercial Distribution

  • 10888857052840 ()
3001-90078

  • Manual orthopaedic bender, reusable

Bioseal Inc. - 00630094110059

Peanut Sponges in Holder
BIOSEAL
11005/50
In Commercial Distribution

  • 10630094110056 ()
  • 00630094110059 ()


  • General-purpose surgical sponge

CytoCell myProbes - 05055844910959

HLF in FITC Spectrum
CYTOCELL LIMITED
MPH16802
In Commercial Distribution

  • 05055844910959 ()


  • Assay development analyte-specific reagent IVD

CytoCell myProbes - 05055844910928

KIAA1509 in FITC Spectrum
CYTOCELL LIMITED
MPH1661
In Commercial Distribution

  • 05055844910928 ()


  • Assay development analyte-specific reagent IVD

CytoCell myProbes - 05055844910911

IGH in FITC Spectrum
CYTOCELL LIMITED
MPH15822
In Commercial Distribution

  • 05055844910911 ()


  • Assay development analyte-specific reagent IVD

CytoCell myProbes - 05055844910898

5p15 in FITC Spectrum
CYTOCELL LIMITED
MPH15432
In Commercial Distribution

  • 05055844910898 ()


  • Assay development analyte-specific reagent IVD

CytoCell myProbes - 05055844910874

CDKN2C in FITC Spectrum
CYTOCELL LIMITED
MPH15422
In Commercial Distribution

  • 05055844910874 ()


  • Assay development analyte-specific reagent IVD

CytoCell myProbes - 05055844910812

EGFR in Aqua Spectrum
CYTOCELL LIMITED
MPH1473
In Commercial Distribution

  • 05055844910812 ()


  • Assay development analyte-specific reagent IVD

CytoCell myProbes - 05055844910799

D7S486 in FITC Spectrum
CYTOCELL LIMITED
MPH1471
In Commercial Distribution

  • 05055844910799 ()


  • Assay development analyte-specific reagent IVD

CytoCell myProbes - 05055844910744

7cen in Aqua Spectrum
CYTOCELL LIMITED
MPH13883
In Commercial Distribution

  • 05055844910744 ()


  • Assay development analyte-specific reagent IVD

CytoCell myProbes - 05055844910737

7q22.1 in FITC Spectrum
CYTOCELL LIMITED
MPH13882
In Commercial Distribution

  • 05055844910737 ()


  • Assay development analyte-specific reagent IVD

CytoCell myProbes - 05055844910713

Xp21.1 in Aqua Spectrum
CYTOCELL LIMITED
MPH13757
In Commercial Distribution

  • 05055844910713 ()


  • Assay development analyte-specific reagent IVD
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