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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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Activa Instrument - E302BISC16029

K-wire Ø1.6 mm, length 300 mm, trocar tip, measuring ring at 150 mm, for 4/4.5 mm cannulated screws
Bioretec Oy
B-ISC-1602
In Commercial Distribution

  • E302BISC16029 ()

  • Width: 1.6 Millimeter
  • Length: 300 Millimeter
B-ISC-1602

  • Orthopaedic bone wire

BR Surgical, LLC - 00840183502904

REEH stitch scissors w/ ribbon handle, sharp tips w/ small hook at end of one blade, 3 3/4"
BR Surgical, LLC
BR08-35463
In Commercial Distribution

  • 00840183502904 ()
BR08-35463

  • Suture scissors

Capsulorrhexis Forceps - 08175700122924

Inamura Capsulorrhexis Fcps, Scleral Tunnel Incision, 1.8mm, 11mm Jaws Marks Cross Action, Flat Handle, Marked at 2.5mm and 5mm
AURORA SURGICAL, LLC
AS7-130T
In Commercial Distribution

  • 08175700122924 ()
AS7-130T

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

MR PHACO - G412CA4700

Morrison Aspirating Cannula 23ga, Smooth blunt tip, Angled 45 Degree at 7mm from bend to tip, 25mm Overall Length
Crestpoint Management Limited
CA470
In Commercial Distribution

  • G412CA4700 ()


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

plusoptiX 16 - 04260184514212

The plusoptiX 16 is a hand held autorefractor and measures refractive data, pupil size, pupil distance and gaze deviation in real time. Both eyes are measured at the same time (binocular) at a distance of one meter (3.3 ft) to the patient eyes.
Plusoptix GmbH
S16
In Commercial Distribution

  • 04260184514212 ()
  • 04260184514229 ()
S16

  • External ocular measurement camera

plusoptiX 16 - 04260184514113

The plusoptiX 16 is a hand held autorefractor and measures refractive data, pupil size, pupil distance and gaze deviation in real time. Both eyes are measured at the same time (binocular) at a distance of one meter (3.3 ft) to the patient eyes.
Plusoptix GmbH
A16
In Commercial Distribution

  • 04260184514113 ()
  • 04260184514120 ()
A16

  • External ocular measurement camera

plusoptiX 12 - 04260184513215

The plusoptiX 12 is a hand held autorefractor and measures refractive data, pupil size, pupil distance and gaze deviation in real time. Both eyes are measured at the same time (binocular) at a distance of one meter (3.3 ft) to the patient eyes.
Plusoptix GmbH
S12R
In Commercial Distribution

  • 04260184513215 ()
  • 04260184513222 ()
S12R

  • External ocular measurement camera

plusoptiX 12 - 04260184513116

The plusoptiX 12 is a hand held autorefractor and measures refractive data, pupil size, pupil distance and gaze deviation in real time. Both eyes are measured at the same time (binocular) at a distance of one meter (3.3 ft) to the patient eyes.
Plusoptix GmbH
A12R
In Commercial Distribution

  • 04260184513116 ()
  • 04260184513123 ()
A12R

  • External ocular measurement camera

plusoptiX 12 - 04260184512218

The plusoptiX 12 is a hand held autorefractor and measures refractive data, pupil size, pupil distance and gaze deviation in real time. Both eyes are measured at the same time (binocular) at a distance of one meter (3.3 ft) to the patient eyes.
Plusoptix GmbH
S12C
In Commercial Distribution

  • 04260184512218 ()
  • 04260184512225 ()


  • External ocular measurement camera

plusoptiX 12 - 04260184512119

The plusoptiX 12 is a hand held autorefractor and measures refractive data, pupil size, pupil distance and gaze deviation in real time. Both eyes are measured at the same time (binocular) at a distance of one meter (3.3 ft) to the patient eyes.
Plusoptix GmbH
A12C
In Commercial Distribution

  • 04260184512119 ()
  • 04260184512126 ()
A12C

  • External ocular measurement camera

CAL B - 05055273205954

The product is intended to be used as a second Calibrator in a two-point calibration. Calibrator B is aspirated from a sample cup at position 18 on the analyser ASP tray at least once every 8 hours depending on the laboratories schedule.
RANDOX LABORATORIES LIMITED
RX3949
In Commercial Distribution

  • 05055273205954 ()
RX3949

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

ComPel MLR Surgical Gown - 00634916709674

ComPel MLR Surgical Gown, 2-Ply Front, Circumferentially Offset Sleeves, Aqua Compel MLR Outer Sleeves and White Compel MLR with Negastat Inner Sleeves, 1-Ply Aqua MLR Comfort Panel Backs, Snap Closures at Neck, Tie Closures at Waist, Barcode, Overcast Safety Stitch Body Size Large
STANDARD TEXTILE CO., INC.
75674395
In Commercial Distribution

  • 00634916709674 ()
  • 10634916709671 ()
75674395

  • Surgical gown, reusable

SUCTION TIP #4 COUPLAND W/HOLE ANGLED DOWN AT 45 DEGREES - D9281061541D450

No Description
W.H. Holden, Inc.
10-6154-1D45
In Commercial Distribution

  • D9281061541D450 ()


  • Dental suction system cannula, reusable

Eckardt Membrane Pic, angled at 120 degrees. (27 gauge / 0.4 mm) - 08717872017150

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
1292.E04
In Commercial Distribution

  • 08717872017150 ()
1292.E04

  • Epiretinal/inner limiting membrane scraper, reusable

Resp-O2 Heat Moisture Exchanger (HME) 1500, Adult, HCH, CO2 Port - 00840117305434

Tidal Volume Range(150-1500mL) Media(Foam), Dead Space(34mL), Breathing Resistance(2.8cm H2O at 60 L/min), Weight(15g), Adult
Dynarex Corporation
30203
In Commercial Distribution

  • 00840117305441 ()
  • 00840117305434 ()


  • Heat/moisture exchanger/microbial medical gas filter

Surgical Direct - B382S345563000

Pre-op Toric Reference Marker, Half Circle With 3 Points At 0, 90 and 180 Degrees On A Round Knurled Handle
Surgical Direct, Inc.
S34556.300
In Commercial Distribution

  • B382S345563000 ()
S34556.300

  • Intraocular retractor, reusable

Novo Surgical Inc. - 00842331183775

o'gawa tying forceps, smooth, 0.5 mm platform, 0.3 mm gap at heel of platform, 4 1/2" (11.0 cm), straight
NOVO SURGICAL, INC.
OP7127-16
In Commercial Distribution

  • 00842331183775 ()
OP7127-16

  • Open-surgery biopsy forceps, reusable

ELMED - 00842180149571

ZEITEL STYLE ORAL-TRACHEAL VOCAL CORD INJECTION NEEDLE. ANGLED UP 25GA. NEEDLE, 20CM WORKING LENGTH, 3.5MM REDUCED TO 1.2MM AT TIP.
ELMED INCORPORATED
40-0613
In Commercial Distribution

  • 00842180149571 ()
40-0613

  • Mouth gag, adjustable, reusable

ELMED - 00842180148666

Extra Deep Cobra Retractor, Cross Hatched Tip, 12.75” Overall Length, 6.75” Handle Length, Blade Width at the widest is 33mm
ELMED INCORPORATED
23-6134
In Commercial Distribution

  • 00842180148666 ()
23-6134

  • Orthopaedic surgical procedure kit, non-medicated, reusable

ELMED - 00842180148482

Mueller-type Femoral Neck Elevator, 13.5” overall length, 6.5” handle length, 25mm blade width at widest. Autoclavable Medical Grade Stainless Steel.
ELMED INCORPORATED
23-3415
In Commercial Distribution

  • 00842180148482 ()
23-3415

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Novo Surgical Inc. - 00842331148408

house "gimmick" elevator, 1.0 mm x 12.0 mm tip angled at 15 degrees, octagonal handle, 6 1/2" (16.5 cm)
NOVO SURGICAL, INC.
E7214-87
In Commercial Distribution

  • 00842331148408 ()
E7214-87

  • Periosteal elevator, reusable

Novo Surgical - 00842331124006

Cooley Vascular Clamp, angled shanks, jaws calibrated at 5.0 mm intervals, 6-1/2" (16.5 cm), 60 degree angle, large jaws
NOVO SURGICAL, INC.
C6661-41
In Commercial Distribution

  • 00842331124006 ()

  • Angle: 60 degree
  • Length: 16.5 Centimeter


  • Surgical A/V-shaped microvessel clamp

Novo Surgical - 00842331123993

Cooley Vascular Clamp, angled shanks, jaws calibrated at 5.0 mm intervals, 6-1/2" (16.5 cm), 60 degree angle, small jaws
NOVO SURGICAL, INC.
C6661-30
In Commercial Distribution

  • 00842331123993 ()

  • Angle: 60 degree
  • Length: 16.5 Centimeter


  • Surgical A/V-shaped microvessel clamp

Novo Surgical - 00842331123986

Cooley Vascular Clamp, angled shanks, jaws calibrated at 5.0 mm intervals, 6-1/2" (16.5 cm), 90 degree angle, large jaws
NOVO SURGICAL, INC.
C6661-39
In Commercial Distribution

  • 00842331123986 ()

  • Angle: 90 degree
  • Length: 16.5 Centimeter


  • Surgical A/V-shaped microvessel clamp

Novo Surgical - 00842331123979

Cooley Vascular Clamp, angled shanks, jaws calibrated at 5.0 mm intervals, 6-1/2" (16.5 cm), 90 degree angle, small jaws
NOVO SURGICAL, INC.
C6661-38
In Commercial Distribution

  • 00842331123979 ()

  • Length: 16.5 Centimeter


  • Surgical A/V-shaped microvessel clamp

Novo Surgical - 00842331117824

Hendren Clamp, very delicate cooley teeth, jaws calibrated at 5.0 mm intervals, 8-1/4" (21.0 cm), jaw base 6.0 mm
NOVO SURGICAL, INC.
5565-40
Not in Commercial Distribution

  • 00842331117824 ()

  • Length: 21 Centimeter
5565-40

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

Novo Surgical - 00842331117862

Hendren Clamp, very delicate cooley teeth, jaws calibrated at 5.0 mm intervals, 8-1/4" (21.0 cm), jaw base 30.0 mm
NOVO SURGICAL, INC.
5565-48
Not in Commercial Distribution

  • 00842331117862 ()

  • Length: 21 Centimeter
5565-48

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

Novo Surgical - 00842331117855

Hendren Clamp, very delicate cooley teeth, jaws calibrated at 5.0 mm intervals, 8-1/4" (21.0 cm), jaw base 24.0 mm
NOVO SURGICAL, INC.
5565-46
Not in Commercial Distribution

  • 00842331117855 ()

  • Length: 21 Centimeter
5565-46

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

Novo Surgical - 00842331117848

Hendren Clamp, very delicate cooley teeth, jaws calibrated at 5.0 mm intervals, 8-1/4" (21.0 cm), jaw base 18.0 mm
NOVO SURGICAL, INC.
5565-44
Not in Commercial Distribution

  • 00842331117848 ()

  • Length: 21 Centimeter
5565-44

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

Novo Surgical - 00842331117831

Hendren Clamp, very delicate cooley teeth, jaws calibrated at 5.0 mm intervals, 8-1/4" (21.0 cm), jaw base 12.0 mm
NOVO SURGICAL, INC.
5565-42
Not in Commercial Distribution

  • 00842331117831 ()

  • Length: 21 Centimeter
5565-42

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

Novo Surgical - 00842331116520

Cooley Vascular Clamp, angled shanks, jaws calibrated at 5.0 mm intervals, 6-1/2" (16.5 cm), 60 degree angle, large jaws
NOVO SURGICAL, INC.
5550-30
Not in Commercial Distribution

  • 00842331116520 ()

  • Length: 16.5 Centimeter
5550-30

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

Novo Surgical - 00842331116513

Cooley Vascular Clamp, angled shanks, jaws calibrated at 5.0 mm intervals, 6-1/2" (16.5 cm), 60 degree angle, small jaws
NOVO SURGICAL, INC.
5550-29
Not in Commercial Distribution

  • 00842331116513 ()

  • Length: 16.5 Centimeter
5550-29

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

Novo Surgical - 00842331116506

Cooley Vascular Clamp, angled shanks, jaws calibrated at 5.0 mm intervals, 6-1/2" (16.5 cm), 90 degree angle, large jaws
NOVO SURGICAL, INC.
5550-28
Not in Commercial Distribution

  • 00842331116506 ()

  • Length: 16.5 Centimeter
5550-28

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

Novo Surgical - 00842331116490

Cooley Vascular Clamp, angled shanks, jaws calibrated at 5.0 mm intervals, 6-1/2" (16.5 cm), 90 degree angle, small jaws
NOVO SURGICAL, INC.
5550-27
Not in Commercial Distribution

  • 00842331116490 ()

  • Length: 16.5 Centimeter
5550-27

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

Novo Surgical - 00842331115967

Cooley Coarctation Clamp - 6 3/4", jaws calibrated at 5.0 mm intervals, 6-3/4" (17.1 cm), angled shanks, straight jaws
NOVO SURGICAL, INC.
5550-12
Not in Commercial Distribution

  • 00842331115967 ()

  • Length: 17.1 Centimeter
5550-12

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

Novo Surgical - 00842331115950

Cooley Coarctation Clamp - 6 3/4", jaws calibrated at 5.0 mm intervals, 6-3/4" (17.1 cm), straight shanks, spoon jaws
NOVO SURGICAL, INC.
5550-11
Not in Commercial Distribution

  • 00842331115950 ()

  • Length: 17.1 Centimeter
5550-11

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

Novo Surgical - 00842331115943

Cooley Coarctation Clamp - 6 3/4", jaws calibrated at 5.0 mm intervals, 6-3/4" (17.1 cm), straight shanks, curved jaws
NOVO SURGICAL, INC.
5550-10
Not in Commercial Distribution

  • 00842331115943 ()

  • Length: 17.1 Centimeter
5550-10

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

Novo Surgical - 00842331115936

Cooley Coarctation Clamp - 6 3/4", jaws calibrated at 5.0 mm intervals, 6-3/4" (17.1 cm), straight shanks, straight jaws
NOVO SURGICAL, INC.
5550-09
Not in Commercial Distribution

  • 00842331115936 ()

  • Length: 17.1 Centimeter
5550-09

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

Novo Surgical - 00842331125348

Hendren Clamp, very delicate cooley teeth, jaws calibrated at 5.0 mm intervals, 8-1/4" (21.0 cm), jaw base 30.0 mm
NOVO SURGICAL, INC.
C6676-59
In Commercial Distribution

  • 00842331125348 ()

  • Length: 21 Centimeter


  • Surgical A/V-shaped microvessel clamp

Novo Surgical - 00842331125331

Hendren Clamp, very delicate cooley teeth, jaws calibrated at 5.0 mm intervals, 8-1/4" (21.0 cm), jaw base 24.0 mm
NOVO SURGICAL, INC.
C6676-57
In Commercial Distribution

  • 00842331125331 ()

  • Length: 21 Centimeter


  • Surgical A/V-shaped microvessel clamp
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