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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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Life Instruments - M93071411002D30

Micro Axial Curette #0 REv Ang Dwn Custom 60 deg at .75
Life Instrument Corporation
714-1100-2D-3
In Commercial Distribution

  • M93071411002D30 ()


  • Bone curette, reusable

C-MATT - 00815073021681

Zone Air Nylon 6 x 35.5 x 84 Cover (tube at foot)
CASCO MANUFACTURING SOLUTIONS, INC.
H10346
In Commercial Distribution

  • 00815073021681 ()
H10346

  • Waterproof bed mattress cover, reusable

C-MATT - 00815073021643

Zone Air Urethane 6 x 35.5 x 84 Cover (tube at foot)
CASCO MANUFACTURING SOLUTIONS, INC.
H10269
In Commercial Distribution

  • 00815073021643 ()
H10269

  • Waterproof bed mattress cover, reusable

Exact Medical Manufacturing, Inc. - 06975424196742

Closed System Camera Drape, with adhesive at open end, 7 x 9
EXACT MEDICAL MANUFACTURING, INC.
VCD5116
In Commercial Distribution

  • 26975424196746 ()
  • 06975424196742 ()
VCD5116

  • Medical equipment/instrument drape, single-use

5/45 Angled Jewelers forceps - 00810072350848

5/45 Angled Jewelers forceps (5 mm long at 45 degree angle)
Cole Instruments Inc
5/45 Angled Jewelers forceps
In Commercial Distribution

  • 00810072350848 ()
371.002

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable

ComPel Isolation Gown - 00634916814521

EasyRelease, ComPel Isolation Gown, AAMI Level 2, Bound Neck, Velcro Hook & Loop Closure at Neck, Tie Closure at Waist, Long Sleeves with Natural White Non-Linting Cuffs, size XL
STANDARD TEXTILE CO., INC.
661Y5044
In Commercial Distribution

  • 01634916814520 ()
  • 00634916814521 ()


  • Isolation gown, reusable

Rugged Oxygen Generator (ROG) - 05060031380002

The ROG is a chemical based portable oxygen generator which generates 99% oxygen for at least 15 minutes at a flow rate of at least 6 Lpm. It is a self-contained device with the oxygen delivered via standard oxygen face mask or nasal cannula.
MOLECULAR PRODUCTS LIMITED
EO209P63N29
In Commercial Distribution

  • 05060031380019 ()
  • 05060031380002 ()


  • Emergency oxygen production unit, reusable

ELMED INCORPORATED - 00198506083723

Spring Retractor, Stainless Steel, Pointed Tips “Sharp”, .300 Loop Thumb Tab on each side, 4” Width at Distal Tips, 4-1/2” Arm Length, Additional Spec’s on File at Elmed
ELMED INCORPORATED
18-32025
In Commercial Distribution

  • 00198506083723 ()
18-32025

  • Hand-held surgical retractor, reusable

microTargeting™ Insertion Tube with Stylet - 00873263005217

microTargeting Insertion Tube with Stylet, nonsterile, at target, for use with Nexframe/Nexdrive
FHC, INC.
66-IT(DB12)-00521
In Commercial Distribution

  • 00873263005217 ()

  • Lumen/Inner Diameter: 1.6 Millimeter
  • Outer Diameter: 1.83 Millimeter
  • Length: 211.6 Millimeter
66-IT(DB12)

  • Intracerebral cannula, implantable

Pick Pack Forte - 00310866002460

Tweezers with the characteristics of the R-55 packing instrument incorporated at the tips.
PASCAL COMPANY, INC.
26200
In Commercial Distribution

  • 00310866002460 ()


  • Gingival retraction cord packing tool

MSI Precision Specialty Instruments - 00194613002060

IRRIGATING CYSTOTOME 25g X 5/8"" STRAIGHT, WITH 1.25mm TIP, ANGLED AT 55°
Med Saver, Inc.
CA5020-SP
In Commercial Distribution

  • 00194613002060 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

A. Titan Instruments - 00841685100872

Osteotome, straight, concave, 2.0mm < 2.5mm, Depth marks at: 8 - 10 - 13 - 15 - 16mm
A. TITAN INSTRUMENTS, INC.
310.01
In Commercial Distribution

  • 00841685100872 ()


  • Dental osteotome

Traction frame - 04527799701513

Electrical Hospital Bed Accessory to be used for patient traction at medical institutions
PARAMOUNT BED CO., LTD.
PC-5121
In Commercial Distribution

  • 04527799701513 ()


  • Bed traction frame

Traction frame - 04527799700387

Electrical Hospital Bed Accessory to be used for patient traction at medical institutions.
PARAMOUNT BED CO., LTD.
KA-86U
In Commercial Distribution

  • 04527799700387 ()


  • Bed traction frame

Traction frame - 04527799700370

Electrical Hospital Bed Accessory to be used for patient traction at medical institutions.
PARAMOUNT BED CO., LTD.
KA-83U
In Commercial Distribution

  • 04527799700370 ()


  • Bed traction frame

Lac-Mac - 00627755056948

Surgical Gown, Level 4, snaps at neck, tie waist, military neckband, Size 2XL
Lac-Mac Limited
005XXCA-2XL
In Commercial Distribution

  • 00627755056948 ()

  • Width: 25 Inch
005XXCA-2XL

  • Surgical gown, reusable

Lac-Mac - 00627755056924

Surgical Gown, Level 4, snaps at neck, tie waist, military neckband, Size 2XL
Lac-Mac Limited
005ABAL-2XL
In Commercial Distribution

  • 00627755056924 ()

  • Width: 25 Inch
005ABAL-2XL

  • Surgical gown, reusable

Lac-Mac - 00627755055941

Surgical Gown, Level 4, snaps at neck, tie waist, military neckband, Size XL
Lac-Mac Limited
005XXCA-XL
In Commercial Distribution

  • 00627755055941 ()

  • Width: 25 Inch
005XXCA-XL

  • Surgical gown, reusable

Lac-Mac - 00627755055927

Surgical Gown, Level 3, snaps at neck, tie waist, military neckband, Size XL
Lac-Mac Limited
005ABAL-XL
In Commercial Distribution

  • 00627755055927 ()

  • Width: 25 Inch
005ABAL-XL

  • Surgical gown, reusable

Lac-Mac - 00627755054944

Surgical Gown, Level 4, snaps at neck, tie waist, military neckband, Size L
Lac-Mac Limited
005XXCA-L
In Commercial Distribution

  • 00627755054944 ()

  • Width: 25 Inch
005XXCA-L

  • Surgical gown, reusable

Lac-Mac - 00627755054920

Surgical Gown, Level 3, snaps at neck, tie waist, military neckband, Size L
Lac-Mac Limited
005ABAL-L
In Commercial Distribution

  • 00627755054920 ()

  • Width: 25 Inch
005ABAL-L

  • Surgical gown, reusable

Lac-Mac - 00627755053947

Surgical Gown, Level 4, snaps at neck, tie waist, military neckband, Size M
Lac-Mac Limited
005XXCA-M
In Commercial Distribution

  • 00627755053947 ()

  • Width: 25 Inch
005XXCA-M

  • Surgical gown, reusable

Lac-Mac - 00627755053923

Surgical Gown, Level 3, snaps at neck, tie waist, military neckband, Size M
Lac-Mac Limited
005ABAL-M
In Commercial Distribution

  • 00627755053923 ()

  • Width: 25 Inch
005ABAL-M

  • Surgical gown, reusable

Lac-Mac - 00627755052940

Surgical Gown, Level 4, snaps at neck, tie waist, military neckband, Size S
Lac-Mac Limited
005XXCA-S
In Commercial Distribution

  • 00627755052940 ()

  • Width: 25 Inch
005XXCA-S

  • Surgical gown, reusable

Lac-Mac - 00627755052926

Surgical Gown, Level 3, snaps at neck, tie waist, military neckband, Size S
Lac-Mac Limited
005ABAL-S
In Commercial Distribution

  • 00627755052926 ()

  • Width: 25 Inch
005ABAL-S

  • Surgical gown, reusable

Berichrom Antithrombin III (A) - 00630414639659

Determination of the functional activity of antithrombin III (AT III) in human plasma
Siemens Healthcare Diagnostics Products GmbH
10873899
In Commercial Distribution

  • 00630414639659 ()
10873899

  • Antithrombin III (ATIII) IVD, kit, chromogenic

Berichrom Antithrombin III (A) - 00630414639444

Determination of the functional activity of antithrombin III (AT III) in human plasma
Siemens Healthcare Diagnostics Products GmbH
10873898
In Commercial Distribution

  • 00630414639444 ()
10873898

  • Antithrombin III (ATIII) IVD, kit, chromogenic

Berichrom® Antithrombin III (A) - 00842768013478

Determination of the functional activity of antithrombin III (AT III) in human plasma
Siemens Healthcare Diagnostics Products GmbH
10446673
In Commercial Distribution

  • 00842768013478 ()
OWWR17

  • Antithrombin III (ATIII) IVD, kit, chromogenic

Berichrom® Antithrombin III (A) - 00842768013461

Determination of the functional activity of antithrombin III (AT III) in human plasma
Siemens Healthcare Diagnostics Products GmbH
10446672
In Commercial Distribution

  • 00842768013461 ()
OWWR15

  • Antithrombin III (ATIII) IVD, kit, chromogenic

Power Dental USA - D94323190

HATCHET 15L R-DOWN CUT, IN/OUT SHAPE, AT 10 O'CLOCK, for Duggan Institute
Power Dental U.S.A. Inc.
2319
In Commercial Distribution

  • D94323190 ()
2319

  • Dressing/utility forceps, scissors-like, reusable
  • Periodontal hoe

Power Dental USA - D94323180

HATCHET 13L L-DOWN CUT, IN/OUT SHAPE, AT 10 O'CLOCK, for Duggan Institute
Power Dental U.S.A. Inc.
2318
In Commercial Distribution

  • D94323180 ()
2318

  • Dressing/utility forceps, scissors-like, reusable
  • Periodontal hoe

ELMED - 00842180187610

Multi-hole suction tubes, Five holes at tip. 7Fr. Working length 6-1/2in (16.5cm).
ELMED INCORPORATED
36-9154
In Commercial Distribution

  • 00842180187610 ()
36-9154

  • ENT surgical procedure kit, non-medicated, reusable

ELMED - 00842180187603

Multi-hole suction tubes, Five holes at tip. 7Fr. Working length 4-1/2in (11.4cm).
ELMED INCORPORATED
36-9152
In Commercial Distribution

  • 00842180187603 ()
36-9152

  • ENT surgical procedure kit, non-medicated, reusable

ELMED - 00842180171398

HOHMANN RETRACTOR, 13.25" OAL, 11 MM BLADE WIDTH AT END, EXTRA DEEP, BLUNT
ELMED INCORPORATED
23-4550-01
In Commercial Distribution

  • 00842180171398 ()
23-4550-01

  • Hand-held surgical retractor, reusable

ELMED - 00842180199576

Multi-hole suction tubes, Five holes at tip. 5Fr. Working length 6-1/2in (16.5cm)
ELMED INCORPORATED
36-9153
In Commercial Distribution

  • 00842180199576 ()
36-9153

  • ENT surgical procedure kit, non-medicated, reusable

ELMED - 00842180196780

HOHMANN RETRACTOR, 13.25" OAL, 11 MM BLADE WIDTH AT END, EXTRA DEEP, BLUNT
ELMED INCORPORATED
ST23455001
In Commercial Distribution

  • 00842180196780 ()
ST23455001

  • Hand-held surgical retractor, reusable

Natus® - 00382830056120

Contour-Flex Valve System, Small, High Pressure At 20 ml/hr: 12.7-18.0 cm H2O
NATUS MEDICAL INCORPORATED
NT14087
In Commercial Distribution


  • High Pressure at 20ml/h: 12.7-18.0cmH2O, Outlet Tubing 91cm Length x 2.3mm O.D. x 1.1mm I.D. (F7), Vent. Cath. 15cm Length x 2.7mm O.D. x 1.4mm I.D. (F8), Right Angle Guide 4.9mm Diam.
NT14087

  • Ventriculo-peritoneal/atrial shunt

Natus® - 00382830056113

Contour-Flex Valve System, Small, Medium Pressure At 20 ml/hr: 6.7-11.8 cm H2O
NATUS MEDICAL INCORPORATED
NT14086
In Commercial Distribution


  • Medium Pressure at 20ml/h: 6.7-11.8cmH2O, Outlet Tubing 91cm Length x 2.3mm O.D. x 1.1mm I.D. (F7), Vent. Cath. 15cm Length x 2.7mm O.D. x 1.4mm I.D. (F8), Right Angle Guide 4.9mm Diam.
NT14086

  • Ventriculo-peritoneal/atrial shunt

Natus® - 00382830056106

Contour-Flex Valve System, Small, Low Pressure At 20 ml/hr: 1.2-5.8 cm H2O
NATUS MEDICAL INCORPORATED
NT14085
In Commercial Distribution


  • Low Pressure at 20ml/h: 1.2-5.8cmH2O, Outlet Tubing 91cm Length x 2.3mm O.D. x 1.1mm I.D. (F7), Vent. Cath. 15cm Length x 2.7mm O.D. x 1.4mm I.D. (F8), Right Angle Guide 4.9mm Diam.
NT14085

  • Ventriculo-peritoneal/atrial shunt

Natus® - 00382830056090

Contour-Flex Valve System, Regular, High Pressure At 20 ml/hr: 12.7-18.0 cm H2O
NATUS MEDICAL INCORPORATED
NT11813
In Commercial Distribution


  • High Pressure at 20ml/h: 12.7-18.0cmH2O, Outlet Tubing 91cm Length x 2.3mm O.D. x 1.1mm I.D. (F7), Vent. Cath. 15cm Length x 2.7mm O.D. x 1.4mm I.D. (F8), Right Angle Guide 4.9mm Diam.
NT11813

  • Ventriculo-peritoneal/atrial shunt

Natus® - 00382830056083

Contour-Flex Valve System, Regular, Medium Pressure At 20 ml/hr: 6.7-11.8 cm H2O
NATUS MEDICAL INCORPORATED
NT11812
In Commercial Distribution


  • Medium Pressure at 20ml/h: 6.7-11.8cmH2O, Outlet Tubing 91cm Length x 2.3mm O.D. x 1.1mm I.D. (F7), Vent. Cath. 15cm Length x 2.7mm O.D. x 1.4mm I.D. (F8), Right Angle Guide 4.9mm Diam.
NT11812

  • Ventriculo-peritoneal/atrial shunt

Natus® - 00382830055994

Contour-Flex Valve System, Regular, Low Pressure At 20 ml/hr: 1.2-5.8 cm H2O
NATUS MEDICAL INCORPORATED
NT11811
In Commercial Distribution


  • Low Pressure at 20ml/h: 1.2-5.8cmH2O, Outlet Tubing 91cm Length x 2.3mm O.D. x 1.1mm I.D. (F7), Vent. Cath. 15cm Length x 2.7mm O.D. x 1.4mm I.D. (F8), Right Angle Guide 4.9mm Diam.
NT11811

  • Ventriculo-peritoneal/atrial shunt

Millennium - 00190776382223

Cottle Chisel, 7 1/4", 4mm, depth markings at 20, 30, 40, & 50mm
Avalign Technologies, Inc.
1-410290
In Commercial Distribution

  • 00190776382223 ()


  • Plastic surgery osteotome

Hayden Medical - 00840319751114

Reverdin Suture Passing Needle 8-1/4" (21cm), curved with 2mm hole at tip
Hayden Medical, Inc.
405-698
In Commercial Distribution

  • 00840319751114 ()
405-698

  • Suture kit, medicated

Hayden Medical - 00840319751084

Reverdin Suture Passing Needle 6" (15cm), slightly curved with 2mm hole at tip
Hayden Medical, Inc.
405-695
In Commercial Distribution

  • 00840319751084 ()
405-695

  • Suture kit, medicated

Hayden Medical - 00840319744550

Adson Dura & Dissecting Hook 8" (20cm), sharp blade 5mm at a right angle
Hayden Medical, Inc.
210-168
In Commercial Distribution

  • 00840319744550 ()
210-168

  • Soft-tissue surgical hook, reusable

Hayden Medical - 00840319739754

Potts-Smith Tissue Forceps 8-1/4" (20.6cm), 1x2 teeth, NON-CONDUCTIVE, exposed at both ends
Hayden Medical, Inc.
120-162NC
In Commercial Distribution

  • 00840319739754 ()
120-162NC

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable

Hayden Medical - 00840319703656

Cushing Bayonet Dressing Forceps 7-1/4" (18.4cm), serrated, non-conductive, exposed at both ends
Hayden Medical, Inc.
120-190NC
In Commercial Distribution

  • 00840319703656 ()
120-190NC

  • Dressing/utility forceps, tweezers-like, reusable

Hayden Medical - 00840319703618

Gerald Tissue Forceps 7" (17.5cm), straight, 1x2 teeth, NON-CONDUCTIVE, exposed at both ends
Hayden Medical, Inc.
120-182NC
In Commercial Distribution

  • 00840319703618 ()
120-182NC

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable

Hayden Medical - 00840319703557

Potts-Smith Tissue Forceps 9-1/2" (23.8cm), 1x2 teeth, NON-CONDUCTIVE, exposed at both ends
Hayden Medical, Inc.
120-164NC
In Commercial Distribution

  • 00840319703557 ()
120-164NC

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
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