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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30 M Corrugated Tube (22 mm,cuffed at 0.15 cm,transparent)
FOREMOUNT ENTERPRISE CO., LTD.
152102
In Commercial Distribution

  • 04719871894002 ()


  • Straight/elbow breathing circuit connector, single-use
Hu Capsule Polisher Ring Tip Set at 90 Degrees, Round Handle
Med Saver, Inc.
5-1756
In Commercial Distribution

  • 00194613119300 ()


  • Ophthalmic surgical probe, reusable
Osteotome, angled, convex, 4.0 mm < 4.5 mm, Depth marks at: 8-10-13-15-16mm
A. TITAN INSTRUMENTS, INC.
321.05
In Commercial Distribution

  • 00841685101091 ()


  • Dental osteotome
Osteotome, straight, convex, 4.5 mm < 5.0 mm, Depth marks at: 8-10-13-15-16mm
A. TITAN INSTRUMENTS, INC.
320.06
In Commercial Distribution

  • 00841685101046 ()


  • Dental osteotome
Osteotome, straight, convex, 3.5 mm < 4.0 mm, Depth marks at: 8-10-12-15-16mm
A. TITAN INSTRUMENTS, INC.
320.04
In Commercial Distribution

  • 00841685101022 ()


  • Dental osteotome
Corrugated Tubing, Blue, Scored at 6 inch, 22 mm, 100 FT
Medi/Nuclear Corporation, Inc.
MN9680
In Commercial Distribution

  • 00857863007871 ()


  • Aerosol delivery tubing
Holds the blood at collection and during processing in the centrifuge.
Reapplix ApS
1
Not in Commercial Distribution

  • 05714188502151 ()


  • Haematological concentrate system preparation kit, platelet concentration
Holds the blood at collection and during processing in the centrifuge.
Reapplix ApS
2
In Commercial Distribution

  • 05714188502106 ()


  • Haematological concentrate system preparation kit, platelet concentration
Kleegman Dilator 10-3/4" (26.9cm), 1-3mm at tips, double ended TEFLON
Hayden Medical, Inc.
290-003T
In Commercial Distribution

  • 00840319708286 ()
290-003T

  • Fixed-diameter cervical dilator, reusable
McKenty Septum Elevator 5-1/2" (13.8cm), curved at tip, 5mm wide
Hayden Medical, Inc.
210-063
In Commercial Distribution

  • 00840319721698 ()
210-063

  • ENT elevator
McKenty Septum Elevator 5-1/2" (13.8cm), curved at tip, 4mm wide
Hayden Medical, Inc.
210-062
In Commercial Distribution

  • 00840319721681 ()
210-062

  • ENT elevator
Potts-Smith Dressing Forceps 12" (30cm), serrated, NON-CONDUCTIVE, exposed at both ends
Hayden Medical, Inc.
120-159NC
In Commercial Distribution

  • 00840319739730 ()
120-159NC

  • Dressing/utility forceps, tweezers-like, reusable
Tissue Forceps 8" (20cm), 1x2 teeth, NON-CONDUCTIVE, exposed at both ends
Hayden Medical, Inc.
120-048NC
In Commercial Distribution

  • 00840319739358 ()
120-048NC

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
Potts-Smith Dressing Forceps 7" (17.5cm), serrated, NON-CONDUCTIVE, exposed at both ends
Hayden Medical, Inc.
120-154NC
In Commercial Distribution

  • 00840319703519 ()
120-154NC

  • Dressing/utility forceps, tweezers-like, reusable
American Rainbow Curette#3/0 Ang 90deg at 2mm from Cup
Life Instrument Corporation
712-0130-1-3-90
In Commercial Distribution

  • M930712013013900 ()


  • Bone curette, reusable
PLIERS, OPERATIVE DEBAKEY AT FCPS/PLIERS OPERATIVE,MODIF. 16 CM, ANGELED
Helmut Zepf Medizintechnik GmbH
50.229.16
In Commercial Distribution

  • EZPF50229160 ()
50.229.16

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
Dermatological and aesthetic laser device operating at 1064 and 532 nm.
QUANTA SYSTEM SPA
PCMS00354
In Commercial Distribution

  • 08059173396368 ()


  • Dermatological frequency-doubled solid-state laser system
Sleeve Protector, ComforTech, White, Sonic Welded, Elastic at both ends, UNIV
Alpha Pro Tech, Inc.
MS-01J06-8TH
In Commercial Distribution

  • 20817583023050 ()
  • 10817583023053 ()
  • 00817583023056 ()
MS-01J06-8TH

  • Surgical sleeve cover
Sleeve Protector, ComforTech, White, Sonic Welded, Elastic at both ends, UNIV
Alpha Pro Tech, Inc.
MS-01J06-8
In Commercial Distribution

  • 20817583023043 ()
  • 10817583023046 ()
  • 00817583023049 ()
MS-01J06-8

  • Surgical sleeve cover
Sleeve Protector, ComforTech, White, Sonic Welded, Elastic at both ends, XL
Alpha Pro Tech, Inc.
MS-01J06-4
In Commercial Distribution

  • 20817583023036 ()
  • 10817583023039 ()
  • 00817583023032 ()
MS-01J06-4

  • Surgical sleeve cover
Sleeve Protector, NuTech, White, Sonic Welded, Elastic at both ends, UNIV
Alpha Pro Tech, Inc.
MS-01606-8
In Commercial Distribution

  • 20817583023012 ()
  • 10817583023015 ()
  • 00817583023018 ()
MS-01606-8

  • Surgical sleeve cover
Sleeve Protector, NuTech, White, Sonic Welded, Elastic at both ends, XL
Alpha Pro Tech, Inc.
MS-01606-4
In Commercial Distribution

  • 20817583023005 ()
  • 10817583023008 ()
  • 00817583023001 ()
MS-01606-4

  • Surgical sleeve cover
Sleeve Protector, GenPro, White, Serged Seams, Elastic at both ends, UNIV
Alpha Pro Tech, Inc.
MS-01135-8
In Commercial Distribution

  • 20817583022992 ()
  • 10817583022995 ()
  • 00817583022998 ()
MS-01135-8

  • Surgical sleeve cover
3.4mm Arthroscopic Sidebiter, 90 Degrees angled at tip, Left, without scoop
Surgical Direct, Inc.
SD20959
In Commercial Distribution

  • B382SD209590 ()
SD20959

  • Endoscope sheath, reusable
3.4mm Arthroscopic Sidebiter, 90 Degree angled at tip, left with scoop
Surgical Direct, Inc.
SD20859
In Commercial Distribution

  • B382SD208590 ()
SD20859

  • Endoscope sheath, reusable
3.4mm Arthroscopic Sidebiter, 90 Degree angled at tip, Right, with Scoop
Surgical Direct, Inc.
SD20809
In Commercial Distribution

  • B382SD208090 ()
SD20809

  • Endoscope sheath, reusable
Blood Culture Collection Kit, Robert Wood Johnson at New Brunswick Only
AERO-MED, LLC
CA10875
In Commercial Distribution

  • 50885380176164 ()
  • 10885380176166 ()
CA10875

  • Phlebotomy kit
Voltage: AC 110-120V 60Hz, Max pressure: 95 psi (preset), Air flow at 0 psi: ~37 l/min, Air flow at 50 psi: ~17 l/min
Dynarex Corporation
33952
In Commercial Distribution

  • 00840117324008 ()
  • 00840117327498 ()


  • Medical device air compressor
Liquid Urine Control Dipstick - Positive, 30 ml. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C.
ALTA DIAGNOSTICS INC
303-2
In Commercial Distribution

  • 30858512007045 ()
  • 10858512007041 ()

  • Total Volume: 30 Milliliter
303-2

  • Multiple urine analyte IVD, control
Liquid Urine Control Dipstick - Negative, 30 ml. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C.
ALTA DIAGNOSTICS INC
303-1
In Commercial Distribution

  • 10858512007034 ()
  • 30858512007038 ()

  • Total Volume: 30 Milliliter
303-1

  • Multiple urine analyte IVD, control
Liquid Urine Control Dipstick - Positive, 20 ml. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C.
ALTA DIAGNOSTICS INC
301-2
In Commercial Distribution

  • 30858512007014 ()
  • 10858512007010 ()

  • Total Volume: 20 Milliliter
301-2

  • Multiple urine analyte IVD, control
Liquid Urine Control Dipstick - Negative, 20 ml. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C.
ALTA DIAGNOSTICS INC
301-1
In Commercial Distribution

  • 30858512007007 ()
  • 10858512007003 ()

  • Total Volume: 20 Milliliter
301-1

  • Multiple urine analyte IVD, control
Toric IOL Reference Marker Blades are positioned at 0, 90, 180 Degrees, Head is angled at 70 degrees, Round Knurled Handle, 98mm Overall Length, Titanium
Crestpoint Management Limited
PH9517T
In Commercial Distribution

  • G412PH9517T0 ()


  • Corneal marker, reusable
Toric IOL Reference Marker Blades are positioned at 0, 90, 180 Degrees, Head is angled at 70 degrees, Round Knurled Handle, 98mm Overall Length, Stainless Steel
Medetz Surgical Instruments LLC
92-840
In Commercial Distribution

  • G223928400 ()


  • Corneal marker, reusable
Toric IOL Reference Marker Blades are positioned at 0, 90, 180 Degrees, Head is angled at 70 degrees, Round Knurled Handle, 98mm Overall Length, Stainless Steel
Crestpoint Management Limited
PH9517
In Commercial Distribution

  • G412PH95170 ()


  • Corneal marker, reusable
Partially Covered Esophageal Stent System
TAEWOONGMEDICAL.CO.,LTD
EST2215B-22
In Commercial Distribution

  • 08809744973500 ()

  • Stent Diameter: 22 Millimeter
  • Stent Length: 15 Centimeter
  • Catheter Working Length: 220 Centimeter
  • 15 mm bare at both ends of the Stent


  • Polymer-metal oesophageal stent
Partially Covered Esophageal Stent System
TAEWOONGMEDICAL.CO.,LTD
EST2214B-22
In Commercial Distribution

  • 08809744973494 ()

  • Stent Diameter: 22 Millimeter
  • Stent Length: 14 Centimeter
  • Catheter Working Length: 220 Centimeter
  • 15 mm bare at both ends of the Stent


  • Polymer-metal oesophageal stent
Partially Covered Esophageal Stent System
TAEWOONGMEDICAL.CO.,LTD
EST2212B-22
In Commercial Distribution

  • 08809744973487 ()

  • Stent Diameter: 22 Millimeter
  • Stent Length: 12 Centimeter
  • Catheter Working Length: 220 Centimeter
  • 15 mm bare at both ends of the Stent


  • Polymer-metal oesophageal stent
Partially Covered Esophageal Stent System
TAEWOONGMEDICAL.CO.,LTD
EST2210B-22
In Commercial Distribution

  • 08809744973470 ()

  • Stent Diameter: 22 Millimeter
  • Stent Length: 10 Centimeter
  • Catheter Working Length: 220 Centimeter
  • 15 mm bare at both ends of the Stent


  • Polymer-metal oesophageal stent
Partially Covered Esophageal Stent System
TAEWOONGMEDICAL.CO.,LTD
EST2208B-22
In Commercial Distribution

  • 08809744973463 ()

  • Stent Diameter: 22 Millimeter
  • Stent Length: 8 Centimeter
  • Catheter Working Length: 220 Centimeter
  • 15 mm bare at both ends of the Stent


  • Polymer-metal oesophageal stent
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