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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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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

Novo Surgical - 00842331125324

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.
C6676-55
In Commercial Distribution

  • 00842331125324 ()

  • Length: 21 Centimeter


  • Surgical A/V-shaped microvessel clamp

Novo Surgical - 00842331125317

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.
C6676-53
In Commercial Distribution

  • 00842331125317 ()

  • Length: 21 Centimeter


  • Surgical A/V-shaped microvessel clamp

Novo Surgical - 00842331125300

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.
C6676-51
In Commercial Distribution

  • 00842331125300 ()

  • Length: 21 Centimeter


  • Surgical A/V-shaped microvessel clamp

Novo Surgical - 00842331123443

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.
C6661-23
In Commercial Distribution

  • 00842331123443 ()

  • Length: 17.1 Centimeter


  • Surgical A/V-shaped microvessel clamp

Novo Surgical - 00842331123436

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.
C6661-22
In Commercial Distribution

  • 00842331123436 ()

  • Length: 17.1 Centimeter


  • Surgical A/V-shaped microvessel clamp

Novo Surgical - 00842331123429

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.
C6661-21
In Commercial Distribution

  • 00842331123429 ()

  • Length: 17.1 Centimeter


  • Surgical A/V-shaped microvessel clamp

Novo Surgical - 00842331123412

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.
C6661-10
In Commercial Distribution

  • 00842331123412 ()

  • Length: 17.1 Centimeter


  • Surgical A/V-shaped microvessel clamp

AngioTouch® Kit - 10841716102131

Model AT P54, p/n 700608-055 Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing
ACIST MEDICAL SYSTEMS, INC.
014644
Not in Commercial Distribution

  • 30841716102135 ()
  • 10841716102131 ()


  • Contrast medium injection system hand controller kit

AngioTouch® Kit - 10841716102001

Model AT P65, p/n 701677-001 Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing
ACIST MEDICAL SYSTEMS, INC.
014645
In Commercial Distribution

  • 30841716102005 ()
  • 10841716102001 ()


  • Contrast medium injection system hand controller kit

AngioTouch® Kit - 10841716101998

Model AT P54, p/n 701675-001 Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing
ACIST MEDICAL SYSTEMS, INC.
014644
In Commercial Distribution

  • 30841716101992 ()
  • 10841716101998 ()


  • Contrast medium injection system hand controller kit

AngioTouch® Kit - 10841716101936

Model AT P54, p/n 700608-054 Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing
ACIST MEDICAL SYSTEMS, INC.
014644
Not in Commercial Distribution

  • 30841716101930 ()
  • 10841716101936 ()


  • Contrast medium injection system hand controller kit

AngioTouch® Kit - 10841716101394

Model AT P54, p/n 701278-008 Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing
ACIST MEDICAL SYSTEMS, INC.
014644
Not in Commercial Distribution

  • 10841716101394 ()
  • 30841716101398 ()


  • Contrast medium injection system hand controller kit

AngioTouch® Kit - 10841716101387

Model AT L65, p/n 700633-003 Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing
ACIST MEDICAL SYSTEMS, INC.
014643
Not in Commercial Distribution

  • 30841716101381 ()
  • 10841716101387 ()


  • Contrast medium injection system hand controller kit

AngioTouch® Kit - 10841716101370

Model AT R54, p/n 700632-003 Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing
ACIST MEDICAL SYSTEMS, INC.
014646
Not in Commercial Distribution

  • 30841716101374 ()
  • 10841716101370 ()


  • Contrast medium injection system hand controller kit

AngioTouch® Kit - 10841716101363

Model AT P65, p/n 701564-010 Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing
ACIST MEDICAL SYSTEMS, INC.
014645
Not in Commercial Distribution

  • 30841716101367 ()
  • 10841716101363 ()


  • Contrast medium injection system hand controller kit

AngioTouch® Kit - 10841716101356

Model AT P54, p/n 700608-049 Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing
ACIST MEDICAL SYSTEMS, INC.
014644
Not in Commercial Distribution

  • 30841716101350 ()
  • 10841716101356 ()


  • Contrast medium injection system hand controller kit

AngioTouch® Kit - 10841716101318

Model AT P65, p/n 701564-008 Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing
ACIST MEDICAL SYSTEMS, INC.
014645
Not in Commercial Distribution

  • 30841716101312 ()
  • 10841716101318 ()


  • Contrast medium injection system hand controller kit

AngioTouch® Kit - 10841716101301

Model AT P54, p/n 700608-048 Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing
ACIST MEDICAL SYSTEMS, INC.
014644
Not in Commercial Distribution

  • 30841716101305 ()
  • 10841716101301 ()


  • Contrast medium injection system hand controller kit

AngioTouch® Kit - 10841716101295

Model AT P54, p/n 700608-047 Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing
ACIST MEDICAL SYSTEMS, INC.
014644
Not in Commercial Distribution

  • 30841716101299 ()
  • 10841716101295 ()


  • Contrast medium injection system hand controller kit

AngioTouch® Kit - 10841716101288

Model AT P54, p/n 700608-046 Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing
ACIST MEDICAL SYSTEMS, INC.
014644
Not in Commercial Distribution

  • 30841716101282 ()
  • 10841716101288 ()


  • Contrast medium injection system hand controller kit
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