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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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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

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

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

Novo Surgical - G586OP7120380

kelman dipstick, 19-gauge cannula, marked at 5.0, 6.0, & 7.0 mm, 2 irrigating ports
NOVO SURGICAL, INC.
OP7120-38
In Commercial Distribution

  • G586OP7120380 ()
OP7120-38

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

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

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

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

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

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

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

Kirwan - 00841019122297

Reusable Bipolar Forceps with 0.7mm Tips Angled 45 Degrees Up at 1cm (Special)
KIRWAN SURGICAL PRODUCTS LLC
10-2402AUS
In Commercial Distribution

  • 00841019122297 ()


  • Open-surgery electrosurgical handpiece/electrode, bipolar, 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

Integra® Miltex® - 10381780424840

Integra® Miltex® Mini-Blumenthal Oral Surgery Rongeur 5", Jaws at 45° Angle
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
22D-424
In Commercial Distribution

  • H83422D4240 ()
  • 10381780424840 ()
22D-424

  • Dental rongeur

Integra® Miltex® - 10381780424659

Integra® Miltex® Blumenthal Oral Surgery Rongeur 7", Jaws at 30° Angle
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
22-481
In Commercial Distribution

  • H834224810 ()
  • 10381780424659 ()
22-481

  • Dental rongeur

Integra® Miltex® - 10381780424642

Integra® Miltex® Blumenthal Oral Surgery Rongeur 6", Jaws at 25° Angle
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
22-480
In Commercial Distribution

  • H834224800 ()
  • 10381780424642 ()
22-480

  • Dental rongeur

Accu-Beam - B17791900

Re-usable fiberoptic handpiece for lasers. 75.1mm bend, Rigid with 30.7mm bend at tip
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
9190
In Commercial Distribution

  • B17791900 ()


  • General/multiple surgical laser system beam guide, reusable

Integra® Jarit® - 10381780207443

Integra® Jarit® Mini-Blumenthal Oral Rongeur, 5-1/4", Jaws at 25° Angle
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
837110
In Commercial Distribution

  • M2748371101 ()
  • 10381780207443 ()
837-110

  • Dental rongeur

Integra® Jarit® - 10381780407843

Integra® Jarit® Mini-Blumenthal Oral Surgery Rongeur 5", Jaws at 45° Angle
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
X33E535
In Commercial Distribution

  • M274X33E5351 ()
  • 10381780407843 ()
X33E535

  • Dental rongeur

Integra® Jarit® - 10381780407782

Integra® Jarit® Blumenthal Oral Surgery Rongeur 7", Jaws at 30° Angle
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
X33592
In Commercial Distribution

  • M274X335921 ()
  • 10381780407782 ()
X33592

  • Dental rongeur

TRIGEN - 00885556808047

KNEE FUSION FEMORAL ANTEGRADE NAIL 11.5MM X 77CM WITH STEP AT 52CM LEFT
Smith & Nephew, Inc.
XT001157-1
In Commercial Distribution

  • 00885556808047 ()
XT001157-1

  • Femur intramedullary nail

Trigen - 00885556742211

KNEE FUSION FEMORAL ANTEGRADE NAIL 11.5-10MM X 78CM WITH STEP AT 57CM RIGHT
Smith & Nephew, Inc.
XT001132-1
In Commercial Distribution

  • 00885556742211 ()
XT001132-1

  • Femur intramedullary nail

Welch Allyn, Inc. - 00732094141795

Welch Allyn Miller #0 Standard Laryngoscope Blade; Lamp at Distal Tip; Stainless Steel
WELCH ALLYN, INC.
901038
In Commercial Distribution

  • 00732094141795 ()
68040

  • Rigid intubation laryngoscope, reusable

Welch Allyn, Inc. - 00732094141788

Welch Allyn Miller #1 Standard Laryngoscope Blade; Lamp at Distal Tip; Stainless Steel
WELCH ALLYN, INC.
901038
In Commercial Distribution

  • 00732094141788 ()
68041

  • Rigid intubation laryngoscope, reusable

Welch Allyn, Inc. - 00732094141764

Welch Allyn Miller #2 Standard Laryngoscope Blade; Lamp at Distal Tip; Stainless Steel
WELCH ALLYN, INC.
901038
In Commercial Distribution

  • 00732094141764 ()
68042

  • Rigid intubation laryngoscope, reusable

Welch Allyn, Inc. - 00732094141740

Welch Allyn Miller #3 Standard Laryngoscope Blade; Lamp at Distal Tip; Stainless Steel
WELCH ALLYN, INC.
901038
In Commercial Distribution

  • 00732094141740 ()
68043

  • Rigid intubation laryngoscope, reusable

Welch Allyn, Inc. - 00732094141726

Welch Allyn Miller #4 Standard Laryngoscope Blade; Lamp at Distal Tip; Stainless Steel
WELCH ALLYN, INC.
901038
In Commercial Distribution

  • 00732094141726 ()
68044

  • Rigid intubation laryngoscope, reusable

Welch Allyn, Inc. - 00732094141702

Welch Allyn Miller #00 Standard Laryngoscope Blade; Lamp at Distal Tip; Stainless Steel
WELCH ALLYN, INC.
901038
In Commercial Distribution

  • 00732094141702 ()
68045

  • Rigid intubation laryngoscope, reusable

VENOUS CLOSE LOOP SYSTEM - 00886333686957

Septum set connected with a 10cc syringe with touchguard stops at 10cc and a 60" Pressure tubing & a 3" small bore tube.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
688695
In Commercial Distribution

  • 50886333686952 ()
  • 00886333686957 ()

  • 10cc syringe stops at 10cc with a 60" pressure tube
688695

  • Invasive-pressure external transducer, single-use

MR PHACO - G412CA16280

Miyoshi Ultimate Vertical Dual Flow Hydrodissectional Cannula 25ga, Angled 45 Degrees at 1.5mm bend to tip, .2mm Dual Ports set at 120 Degrees, Smooth closed sandblasted tip, 22mm Overall Length
Crestpoint Management Limited
CA1628
In Commercial Distribution

  • G412CA16280 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable

MR PHACO - G412CA16270

Miyoshi Ultimate Vertical Dual Flow Hydrodissectional Cannula 23ga, Angled 45 Degrees at 1.5mm bend to tip, .2mm Dual Ports set at 120 Degrees, Smooth closed sandblasted tip, 22mm Overall Length
Crestpoint Management Limited
CA1627
In Commercial Distribution

  • G412CA16270 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable

Emay - 04897087206120

It's designed for family and individual users to track heart activity at home, at work or on a trip in case of cardiac situation that needs evaluation on the spot.
EMAY (HK) LIMITED
EMG-6L
In Commercial Distribution

  • 04897087206120 ()


  • Telemetric electrocardiographic ambulatory recorder

Emay - 04897087200203

It's designed for family and individual users to track heart activity at home, at work or on a trip in case of cardiac situation that needs evaluation on the spot.
EMAY (HK) LIMITED
EMG-20
In Commercial Distribution

  • 04897087200203 ()


  • Electrocardiographic monitor

Emay - 04897087200104

It's designed for family and individual users to track heart activity at home, at work or on a trip in case of cardiac situation that needs evaluation on the spot.
EMAY (HK) LIMITED
EMG-10
Not in Commercial Distribution

  • 04897087200104 ()


  • Electrocardiographic monitor

HUMAN ASSAYED MULTI-SERA/ASSAYED CHEMISTRY PREMIUM PLUS - LEVEL 2 & 3 (HUM ASY - 05055273203813

The Human Assayed Multi-sera is supplied at 2 levels, level 2 and 3. Target values and ranges are supplied for the analytes listed in the values section at both levels.
RANDOX LABORATORIES LIMITED
HS2611
In Commercial Distribution

  • 05055273203813 ()


  • Multiple-type clinical chemistry analyte profile IVD, control

HUMAN ASSAYED MULTI-SERA/ASSAYED CHEMISTRY PREMIUM PLUS - LEVEL 2 (HUM ASY CONTR - 05055273203783

The Human Assayed Multi-sera is supplied at 2 levels, level 2 and 3. Target values and ranges are supplied for the analytes listed in the values section at both levels.
RANDOX LABORATORIES LIMITED
HN1530
In Commercial Distribution

  • 05055273203783 ()


  • Multiple-type clinical chemistry analyte profile IVD, control

HUMAN ASSAYED MULTI-SERA/ASSAYED CHEMISTRY PREMIUM PLUS - LEVEL 3 (HUM ASY CONTR - 05055273203608

The Human Assayed Multi-sera is supplied at 2 levels, level 2 and 3. Target values and ranges are supplied for the analytes listed in the values section at both levels.
RANDOX LABORATORIES LIMITED
HE1532
In Commercial Distribution

  • 05055273203608 ()


  • Multiple-type clinical chemistry analyte profile IVD, control

ProMax Surgical Gown - 00634916795493

ProMax Surgical Gown, MLR Front Yoke, Comfort Panel Back with Negastat, Snap Closures at Neck, Tape Tie Closures at Waist, With QCM, Circumferentially Offset Sleeves, Double-needle Flat Felled Chainstitch Construction
STANDARD TEXTILE CO., INC.
75614905
In Commercial Distribution

  • 00634916795493 ()


  • Surgical gown, reusable
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