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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Reusable Bipolar Forceps with Tips Angled Up 45 Deg. at 5mm (Special)
KIRWAN SURGICAL PRODUCTS LLC
10-5603NSS
In Commercial Distribution

  • 00841019115244 ()


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Rhoton Hook Overall Length 7 1/2" Angled at 90 Degrees Blunt
Med Saver, Inc.
1412-4896-010BX
In Commercial Distribution

  • 00194613060046 ()


  • Open-surgery dissector
Rhoton Hook Overall Length 7 1/2" Angled at 90 Degrees Semi-Sharp
Med Saver, Inc.
1412-4896-009BX
In Commercial Distribution

  • 00194613060039 ()


  • Open-surgery dissector
Heaney "AT" Hysterectomy Forceps, angled, 4x4 ratchet, TW 4.7mm, OL 200mm (8")
Avalign Technologies, Inc.
VM57-3957
In Commercial Distribution

  • 00190776128968 ()


  • Open-surgery biopsy forceps, reusable
Reusable Bipolar Forceps Angled Up 45 Degrees with Bend at 3mm (Special)
KIRWAN SURGICAL PRODUCTS LLC
12-1436AUS
In Commercial Distribution

  • 00841019120026 ()


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Reusable Bipolar Forceps Angled Down 45 Degrees with Bend at 3mm (Special)
KIRWAN SURGICAL PRODUCTS LLC
12-1436AUS
In Commercial Distribution

  • 00841019120019 ()


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Lumina-nrg Fat Iron pro at home body fat slimming & skin tightening device
Heatinaclick LLC
6619
In Commercial Distribution

  • 00850018806619 ()


  • Home-use radio-frequency skin contouring unit
Rhoton Hook Overall Length 7 1/2" Angled at 45 Degrees Semi-Sharp
Med Saver, Inc.
1412-4896-011BX
In Commercial Distribution

  • 00194613090463 ()


  • Open-surgery dissector
zenith meeker forceps, jaws angled at 90 degrees, 10-3/4" (27.0 cm)
NOVO SURGICAL, INC.
G96583-71
In Commercial Distribution

  • G586G96583710 ()
G96583-71

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
Osteotome, straight, convex, 2.5mm < 3.0mmDepth marks at: 8 - 10 - 13 - 15 - 16mm
A. TITAN INSTRUMENTS, INC.
320.02
In Commercial Distribution

  • 00841685101008 ()


  • Dental osteotome
Osteotome, straight, convex, 2.0mm < 2.5mmDepth marks at: 8 - 10 - 13 - 15 - 16mm
A. TITAN INSTRUMENTS, INC.
320.01
In Commercial Distribution

  • 00841685100995 ()


  • Dental osteotome
Osteotome, offset, concave, 3.0mm < 3.5mmDepth marks at: 8 - 10 - 13 - 15 - 16mm
A. TITAN INSTRUMENTS, INC.
311.03
In Commercial Distribution

  • 00841685100957 ()


  • Dental osteotome
Osteotome, offset, concave, 2.5mm < 3.0mmDepth marks at: 8 - 10 - 13 - 15 - 16mm
A. TITAN INSTRUMENTS, INC.
311.02
In Commercial Distribution

  • 00841685100940 ()


  • Dental osteotome
Osteotome, offset, concave, 2.0mm < 2.5mmDepth marks at: 8 - 10 - 13 - 15 - 16mm
A. TITAN INSTRUMENTS, INC.
311.01
In Commercial Distribution

  • 00841685100933 ()


  • Dental osteotome
Osteotome, straight, concave, 3.0mm < 3.5mmDepth marks at: 8 - 10 - 13 - 15 - 16mm
A. TITAN INSTRUMENTS, INC.
310.03
In Commercial Distribution

  • 00841685100896 ()


  • Dental osteotome
Osteotome, straight, concave, 2.5mm < 3.0mmDepth marks at: 8 - 10 - 13 - 15 - 16mm
A. TITAN INSTRUMENTS, INC.
310.02
In Commercial Distribution

  • 00841685100889 ()


  • Dental osteotome
Breast Retractor, 150x16mm blade w/Fiber Optic & Suction, Insulated at wkg end.
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
ASSI.ABR27826
In Commercial Distribution

  • 00841645123804 ()


  • Hand-held surgical retractor, reusable
Osteotome, angled, convex, 3.0mm < 3.5mmDepth marks at: 8 - 10 - 13 - 15 - 16mm
A. TITAN INSTRUMENTS, INC.
321.03
In Commercial Distribution

  • 00841685101077 ()


  • Dental osteotome
Osteotome, angled, convex, 2.5mm < 3.0mmDepth marks at: 8 - 10 - 13 - 15 - 16mm
A. TITAN INSTRUMENTS, INC.
321.02
In Commercial Distribution

  • 00841685101060 ()


  • Dental osteotome
Osteotome, angled, convex, 2.0mm < 2.5mmDepth marks at: 8 - 10 - 13 - 15 - 16mm
A. TITAN INSTRUMENTS, INC.
321.01
In Commercial Distribution

  • 00841685101053 ()


  • Dental osteotome
Osteotome, straight, convex, 3.0mm < 3.5mmDepth marks at: 8 - 10 - 13 - 15 - 16mm
A. TITAN INSTRUMENTS, INC.
320.03
In Commercial Distribution

  • 00841685101015 ()


  • Dental osteotome
MOST, 20-2B FINAL ASSEMBLY 10,000 LITERS AT 2250 PSI, 2 BRASS CYLINDERS
Pacific Consolidated Industries LLC
MOST 20-2B
In Commercial Distribution

  • 00860007698231 ()
793080-002

  • Bulk oxygen concentration system
CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC
CORETESTS, INC.
ACT21002-4
In Commercial Distribution

  • 10850042559564 ()
  • 00850042559567 ()
  • 00850042559543 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC
CORETESTS, INC.
ACT21002-2
In Commercial Distribution

  • 10850042559557 ()
  • 00850042559550 ()
  • 00850042559543 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC
CORETESTS, INC.
ACT21002-5
In Commercial Distribution

  • 10850042559533 ()
  • 00850042559536 ()
  • 00850042559543 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC
CORETESTS, INC.
ACT21002-1
In Commercial Distribution

  • 00850042559529 ()
  • 10850042559526 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Gerald Dressing Forceps 7" (17.5cm), straight, serrated, NON-CONDUCTIVE, exposed at both ends
Hayden Medical, Inc.
120-180NC
In Commercial Distribution

  • 00840319739792 ()
120-180NC

  • Dressing/utility forceps, tweezers-like, reusable
Potts-Smith Tissue Forceps 12" (30cm), 1x2 teeth, NON-CONDUCTIVE, exposed at both ends
Hayden Medical, Inc.
120-165NC
In Commercial Distribution

  • 00840319739761 ()
120-165NC

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
Potts-Smith Tissue Forceps 7" (17.5cm), 1x2 teeth, NON-CONDUCTIVE, exposed at both ends
Hayden Medical, Inc.
120-160NC
In Commercial Distribution

  • 00840319739747 ()
120-160NC

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
Reverdin Suture Passing Needle 6" (15cm), curved with 2mm hole at tip
Hayden Medical, Inc.
405-697
In Commercial Distribution

  • 00840319751107 ()
405-697

  • Suture kit, medicated
Adson Dura Hook 8" (20cm), blunt 5mm hook at a right angle
Hayden Medical, Inc.
210-169
In Commercial Distribution

  • 00840319744567 ()
210-169

  • Soft-tissue surgical hook, reusable
Potts-Smith Dressing Forceps 9-1/2" (23.8cm), serrated, NON-CONDUCTIVE, exposed at both ends
Hayden Medical, Inc.
120-158NC
In Commercial Distribution

  • 00840319703540 ()
120-158NC

  • Dressing/utility forceps, tweezers-like, reusable
Potts-Smith Dressing Forceps 8-1/4" (20.6cm), serrated, NON-CONDUCTIVE, exposed at both ends
Hayden Medical, Inc.
120-156NC
In Commercial Distribution

  • 00840319703526 ()
120-156NC

  • Dressing/utility forceps, tweezers-like, reusable
Seeley Hydrodissection Cannula 26ga Angled at 12mm, Flat Tip, 15mm Overall Length
Medetz Surgical Instruments LLC
12-64945
In Commercial Distribution

  • G22312649450 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Micro Axial Curette #0 REv Ang Dwn Custom 60 deg at .75
Life Instrument Corporation
714-1100-2D-3
In Commercial Distribution

  • M93071411002D30 ()


  • Bone curette, reusable
Twist Drill 4.2mm cylindrical, with laser marks at 6-8-10-12-14-16mm. Made of Ceramic.
CERAROOT SL.
002.005
In Commercial Distribution

  • 08435453900331 ()

  • Outer Diameter: 4.2 Millimeter
002.005

  • Fixture/appliance dental drill bit, reusable
Twist Drill 3.5mm cylindrical, with laser marks at 6-8-10-12-14-16mm. Made of Ceramic.
CERAROOT SL.
002.004
In Commercial Distribution

  • 08435453900324 ()

  • Outer Diameter: 3.5 Millimeter
002.004

  • Fixture/appliance dental drill bit, reusable
Twist Drill 2.8mm cylindrical, with laser marks at 6-8-10-12-14-16mm. Made of Ceramic.
CERAROOT SL.
002.003
In Commercial Distribution

  • 08435453900317 ()

  • Outer Diameter: 2.8 Millimeter
002.003

  • Fixture/appliance dental drill bit, reusable
Twist Drill 2.3mm cylindrical, with laser marks at 6-8-10-12-14-16mm. Made of Ceramic.
CERAROOT SL.
002.002
In Commercial Distribution

  • 08435453900300 ()

  • Outer Diameter: 2.3 Millimeter
002.002

  • Fixture/appliance dental drill bit, reusable
Twist Drill 4.2mm cylindrical, with laser marks at 6-8-10-12-14-16mm. Made of Steel.
CERAROOT SL.
001.005
In Commercial Distribution

  • 08435453900294 ()

  • Outer Diameter: 4.2 Millimeter
001.005

  • Fixture/appliance dental drill bit, reusable
Twist Drill 3.5mm cylindrical, with laser marks at 6-8-10-12-14-16mm. Made of Steel.
CERAROOT SL.
001.004
In Commercial Distribution

  • 08435453900287 ()

  • Outer Diameter: 3.5 Millimeter
001.004

  • Fixture/appliance dental drill bit, reusable
Twist Drill 2.8mm cylindrical, with laser marks at 6-8-10-12-14-16mm. Made of Steel.
CERAROOT SL.
001.003
In Commercial Distribution

  • 08435453900270 ()

  • Outer Diameter: 2.3 Millimeter
  • Outer Diameter: 2.8 Millimeter
001.003

  • Fixture/appliance dental drill bit, reusable
Twist Drill 2.3mm cylindrical, with laser marks at 6-8-10-12-14-16mm. Made of Steel.
CERAROOT SL.
001.002
In Commercial Distribution

  • 08435453900263 ()

  • Outer Diameter: 2.3 Millimeter
001.002

  • Fixture/appliance dental drill bit, reusable
Sleeve Protector, BarrierTech, Black, Serged Regular Style, Elastic at both ends,UNIV
Alpha Pro Tech, Inc.
MS-01B512-8
In Commercial Distribution

  • 20817583023029 ()
  • 10817583023022 ()
  • 00817583023025 ()
MS-01B512-8

  • Surgical sleeve cover
3.4 mm Arthroscopic Sidebiter, 90 Degrees angled at tip, Right, without Scoop
Surgical Direct, Inc.
SD20909
In Commercial Distribution

  • B382SD209090 ()
SD20909

  • Endoscope sheath, reusable
Blood Culture Collection Kit, Pediatric, Robert Wood Johnson at New Brunswick Only
AERO-MED, LLC
CA27075
In Commercial Distribution

  • 50885380176171 ()
  • 10885380176173 ()
CA27075

  • Phlebotomy kit
EasyRelease, ComPel Isolation Gown, AAMI Level 2, Bound Neck, Velcro Hook & Loop Closure at Neck, Tie Closure at Waist, Long Sleeves with Natural White Non-Linting Cuffs, size XL
STANDARD TEXTILE CO., INC.
661Y5044
In Commercial Distribution

  • 01634916814520 ()
  • 00634916814521 ()


  • Isolation gown, reusable
The ROG is a chemical based portable oxygen generator which generates 99% oxygen for at least 15 minutes at a flow rate of at least 6 Lpm. It is a self-contained device with the oxygen delivered via standard oxygen face mask or nasal cannula.
MOLECULAR PRODUCTS LIMITED
EO209P63N29
In Commercial Distribution

  • 05060031380019 ()
  • 05060031380002 ()


  • Emergency oxygen production unit, reusable
Sterile transparent PVC suction tube with 2 connectors at the extremities. Length: 2.70m
HYGITECH
HY-12025
In Commercial Distribution

  • 03615140001915 ()
  • 03615140001908 ()
  • 03615140001922 ()
HY-12025

  • Airway suction catheter
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
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