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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No Description
U&C International Co.,Ltd
W ML AT B2 20
In Commercial Distribution

  • 08800118612285 ()


  • Dental appliance fabrication material, ceramic
No Description
U&C International Co.,Ltd
W ML AT B2 18
In Commercial Distribution

  • 08800118612278 ()


  • Dental appliance fabrication material, ceramic
No Description
U&C International Co.,Ltd
W ML AT B2 16
In Commercial Distribution

  • 08800118612261 ()


  • Dental appliance fabrication material, ceramic
No Description
U&C International Co.,Ltd
W ML AT B2 14
In Commercial Distribution

  • 08800118612254 ()


  • Dental appliance fabrication material, ceramic
No Description
U&C International Co.,Ltd
W ML AT B2 12
In Commercial Distribution

  • 08800118612247 ()


  • Dental appliance fabrication material, ceramic
No Description
U&C International Co.,Ltd
W ML AT B1 25
In Commercial Distribution

  • 08800118612230 ()


  • Dental appliance fabrication material, ceramic
No Description
U&C International Co.,Ltd
W ML AT B1 22
In Commercial Distribution

  • 08800118612223 ()


  • Dental appliance fabrication material, ceramic
No Description
U&C International Co.,Ltd
W ML AT B1 20
In Commercial Distribution

  • 08800118612216 ()


  • Dental appliance fabrication material, ceramic
No Description
U&C International Co.,Ltd
W ML AT B1 18
In Commercial Distribution

  • 08800118612209 ()


  • Dental appliance fabrication material, ceramic
No Description
U&C International Co.,Ltd
W ML AT B1 16
In Commercial Distribution

  • 08800118612193 ()


  • Dental appliance fabrication material, ceramic
No Description
U&C International Co.,Ltd
W ML AT B1 14
In Commercial Distribution

  • 08800118612186 ()


  • Dental appliance fabrication material, ceramic
No Description
U&C International Co.,Ltd
W ML AT B1 12
In Commercial Distribution

  • 08800118612179 ()


  • Dental appliance fabrication material, ceramic
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
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
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
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
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
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
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
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
No Description
W.H. Holden, Inc.
10-6154-1D45
In Commercial Distribution

  • D9281061541D450 ()


  • Dental suction system cannula, reusable
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
VacuCord knitted gingival non-medicated retraction cord for rapid tissue displacement and absorption of fluid at the sulcus Size 2, 100"
HO DENTAL COMPANY LLC
Size 2
In Commercial Distribution

  • 00850211006342 ()


  • Dental floss
VacuCord knitted gingival non-medicated retraction cord for rapid tissue displacement and absorption of fluid at the sulcus Size 0, 100"
HO DENTAL COMPANY LLC
Size 0
In Commercial Distribution

  • 00850211006328 ()


  • Dental floss
SUBDURAL GRID ELECTRODE, PLATINUM, 16 CONTACT, 2X8, RADIOPAQUE "L" AT CONTACT #1, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2110-16-066-NS
In Commercial Distribution

  • 00650551076575 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2110-16-066-NS

  • Cortical electrode
SUBDURAL GRID ELECTRODE, PLATINUM, 16 CONTACT, 4X4, RADIOPAQUE "L" AT CONTACT #1, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2110-16-062-NS
In Commercial Distribution

  • 00650551076490 ()

  • Thickness 0.5 Millimeter
  • Contact Diameter 3 Millimeter
2110-16-062-NS

  • Cortical electrode
SUBDURAL GRID ELECTRODE, PLATINUM, 16 CONTACT, 2X8, RADIOPAQUE "L" AT CONTACT #1, TEXTURED, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2110TX-16-066-NS
In Commercial Distribution

  • 00650551076582 ()

  • Thickness 0.5 Millimeter
  • Contact Diameter 3 Millimeter
2110TX-16-066-NS

  • Cortical electrode
SUBDURAL GRID ELECTRODE, PLATINUM, 16 CONTACT, 4X4, RADIOPAQUE "L" AT CONTACT #1, TEXTURED, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2110TX-16-062-NS
In Commercial Distribution

  • 00650551076506 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2110TX-16-062-NS

  • Cortical electrode
VacuCord knitted gingival non-medicated retraction cord for rapid tissue displacement and absorption of fluid at the sulcus Size 1, 100"
HO DENTAL COMPANY LLC
Size 1
In Commercial Distribution

  • 00850211006335 ()


  • Dental floss
VacuCord knitted gingival non-medicated retraction cord for rapid tissue displacement and absorption of fluid at the sulcus Size 00, 100"
HO DENTAL COMPANY LLC
Size 00
In Commercial Distribution

  • 00850211006311 ()


  • Dental floss
The Good Morning Snore Solution - An intraoral device for the reduction of snoring for adults at least 18 years old.
MPowRx Health and Wellness Products 2012
1
In Commercial Distribution

  • 00627843257127 ()


  • Tongue-retaining sleep-disordered breathing orthosis
BACK VEST PRECAUTION GOWN, Sleeveless, 1 Ply RipStop with Negastat, Bound Neck & Armholes, Tape Ties at Back Closure, Size Large
STANDARD TEXTILE CO., INC.
66147015
In Commercial Distribution

  • 00634916068597 ()
  • 10634916068594 ()
66147015

  • Isolation gown, reusable
PIEZO BONE SURGERY TIPS FOR SURGIMASTER AND SURGIMASTER II,DUS3 HIGHLY SOPHISTICATED OF NARROW BONE AT THIN REGIONS OF ANATOMY
Power Dental U.S.A. Inc.
8100-5
In Commercial Distribution

  • D94381005 ()
8100-5

  • Dressing/utility forceps, scissors-like, reusable
  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
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
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
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
AUSTIN Measuring probe(caliper)determine length of stapes prosthesis, 6 1/4" 160 mm, markings at 3.5 - 4.0 - 4.5 mm
RZ-Medizintechnik GmbH
410-142-166
In Commercial Distribution

  • 04049197304566 ()
410-142-166

  • General surgery wound probe/packer
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
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
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
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
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
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
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
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
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
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
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
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
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
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