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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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A flexible device intended to be inserted through an endoscope to ligate, cauterize, and cut polyps, or other mucosal lesions in the gastrointestinal (GI) tract, using high frequency current during endotherapy. It consists of a flexible insulated insertion sheath, a snare loop attached to the distal end of the sheath, and an operating wire connected to both the loop and a handle which controls the operating wire. The proximal end of the operating wire is connected to a high frequency power supply unit. This is a single use device.
HOBBS MEDICAL, INC.
4560OLY
In Commercial Distribution

  • M8494560OLY0 ()
  • M8494560OLY1 ()
4560OLY

  • Flexible polypectomy snare, single-use
A flexible device intended to be inserted through an endoscope to ligate, cauterize, and cut polyps, or other mucosal lesions in the gastrointestinal (GI) tract, using high frequency current during endotherapy. It consists of a flexible insulated insertion sheath, a snare loop attached to the distal end of the sheath, and an operating wire connected to both the loop and a handle which controls the operating wire. The proximal end of the operating wire is connected to a high frequency power supply unit. This is a single use device.
HOBBS MEDICAL, INC.
4560
In Commercial Distribution

  • M84945600 ()
  • M84945601 ()
4560

  • Flexible polypectomy snare, single-use
The Hobbs Microbiology Brush is intended to be used in combination with a compatible flexible endoscope to collect cells of the mucosa for pathological diagnosis during endoscopy. It is inserted through the working channel of the endoscope and consists of a flexible insertion portion made of a metal coil inside a plastic tube, whose distal end is equipped with plastic bristles for harvesting and protecting mucosal cells, e.g., during endoscopy. This is a single-use device.
HOBBS MEDICAL, INC.
4352
In Commercial Distribution

  • M84943521 ()
  • M84943520 ()
4352

  • Flexible endoscopic cytology brush, single-use
The Hobbs Microbiology Brush is intended to be used in combination with a compatible flexible endoscope to collect cells of the mucosa for pathological diagnosis during endoscopy. It is inserted through the working channel of the endoscope and consists of a flexible insertion portion made of a metal coil inside a plastic tube, whose distal end is equipped with plastic bristles for harvesting and protecting mucosal cells, e.g., during endoscopy. This is a single-use device.
HOBBS MEDICAL, INC.
4320
In Commercial Distribution

  • M84943201 ()
  • M84943200 ()
4320

  • Flexible endoscopic cytology brush, single-use
The Hobbs Microbiology Brush is intended to be used in combination with a compatible flexible endoscope to collect cells of the mucosa for pathological diagnosis during endoscopy. It is inserted through the working channel of the endoscope and consists of a flexible insertion portion made of a metal coil inside a plastic tube, whose distal end is equipped with plastic bristles for harvesting and protecting mucosal cells, e.g., during endoscopy. This is a single-use device.
HOBBS MEDICAL, INC.
4310
In Commercial Distribution

  • M84943100 ()
  • M84943101 ()
4310

  • Flexible endoscopic cytology brush, single-use
The Nasal Cytology Brush consists of bristles at the distal end which is then set into a handle that is intended to collect cells from the nasal passages. The cells are used for histopathological analysis. This is a single-use device.
HOBBS MEDICAL, INC.
4291
In Commercial Distribution

  • M84942912 ()
  • M84942910 ()
4291

  • General-purpose cytology brush
The Nasal Cytology Brush consists of bristles at the distal end which is then set into a handle that is intended to collect cells from the nasal passages. The cells are used for histopathological analysis. This is a single-use device.
HOBBS MEDICAL, INC.
4290
In Commercial Distribution

  • M84942900 ()
  • M84942902 ()
4290

  • General-purpose cytology brush
UHMWPE Suture for SharpShooter®
IVY SPORTS MEDICINE LLC
HS4704
Not in Commercial Distribution

  • M928HS47041 ()
  • M928HS47042 ()

  • USP 2-0 (except for diameter)
HS4704

  • Polyolefin/fluoropolymer suture, monofilament
10ml oral tip
Carelife (usa) Inc.
1
In Commercial Distribution

  • M922CTSOS10100B5 ()
  • M922CTSOS10100B3 ()
  • M922CTSOS10100B0 ()
CTSOS10

  • ENFit oral/enteral syringe, single-use
Polyester Suture for SharpShooter®
IVY SPORTS MEDICINE LLC
4701
Not in Commercial Distribution

  • M92847012 ()
  • M92847011 ()

  • USP 2-0
4701

  • Polyester suture, non-bioabsorbable, multifilament
No Description
Intersect Ent, Inc.
10061
In Commercial Distribution

  • M92710061 ()
  • M92710065 ()


  • Paranasal sinus spacer
No Description
H & O Equipments SA
N2O 8g cartridges and filters
In Commercial Distribution

  • B386SNOR112 ()
  • B386SNOR101 ()
  • B386SNOR100 ()
S-NOR10

  • Nitrous oxide gas cartridge
No Description
H & O Equipments SA
16g N2O cartridges
In Commercial Distribution

  • B386SHONOCXPR12S062 ()
  • B386SHONOCXPR12S061 ()
  • B386SHONOCXPR12S060 ()
S-HO-NOCX-PR-12-S06

  • Nitrous oxide gas cartridge
No Description
H & O Equipments SA
8g N2O cartridges
In Commercial Distribution

  • B386SHONOCX12S24PR2 ()
  • B386SHONOCX12S24PR1 ()
  • B386SHONOCX12S24PR0 ()
S-HO-NOCX-12-S24-PR

  • Nitrous oxide gas cartridge
No Description
H & O Equipments SA
23g N2O cartridges
In Commercial Distribution

  • B386SHONO2312S06PR2 ()
  • B386SHONO23XXS06PR1 ()
  • B386SHONO23XXS06PR0 ()
S-HO-NO23-XX-S06-PR

  • Nitrous oxide gas cartridge
No Description
H & O Equipments SA
8g N2O cartridges for Freezpen
In Commercial Distribution

  • B386CLN2O8GCARTON2 ()
  • B386CLN2O8GBOX1 ()
  • B386CLN2O8GBOX0 ()
CL-N2O-8G-BOX

  • Nitrous oxide gas cartridge
No Description
H & O Equipments SA
16g cartridges for Freezpen
In Commercial Distribution

  • B386CLN2O16GUNCARTON2 ()
  • B386CLN2O16GUNBOX1 ()
  • B386CLN2O16GUNBOX0 ()
CL-N2O-16G-UNBOX

  • General cryosurgical system, cryogen gas, mechanical
25ga ILM Elevator
Vortex Surgical, Inc.
VS0300.25
In Commercial Distribution

  • B384VS0300255 ()
  • B384VS0300251 ()

  • Needle Gauge: 25 Gauge
VS0300.25

  • General-purpose ophthalmic hook, single-use
23ga ILM elevator
Vortex Surgical, Inc.
VS0300.23
In Commercial Distribution

  • B384VS0300235 ()
  • B384VS0300231 ()

  • Needle Gauge: 23 Gauge
VS300.23

  • General-purpose ophthalmic hook, single-use
27ga Soft Tip Cannula
Vortex Surgical, Inc.
VS0200.27
In Commercial Distribution

  • B384VS0200275 ()
  • B384VS02002719 ()
VS0200.27

  • Vitrectomy fluid/gas handling handpiece/cannula
25ga Soft Tip Cannula
Vortex Surgical, Inc.
VS0200.25
In Commercial Distribution

  • B384VS0200255 ()
  • B384VS0200251 ()

  • Needle Gauge: 25 Gauge
VS0200.25

  • Vitrectomy fluid/gas handling handpiece/cannula
23ga Soft Tip Cannula
Vortex Surgical, Inc.
VS0200.23
In Commercial Distribution

  • B384VS0200235 ()
  • B384VS0200231 ()

  • Needle Gauge: 23 Gauge
VS0200.23

  • Vitrectomy fluid/gas handling handpiece/cannula
25ga Bending Laser Probe - Iridex Compatible
Vortex Surgical, Inc.
VS0140.25I
In Commercial Distribution

  • B384VS014025I5 ()
  • B384VS014025I1 ()

  • Needle Gauge: 25 Gauge
VS0140.25I

  • Ophthalmic laser system beam guide
25ga Bending Laser Probe - Alcon Compatible
Vortex Surgical, Inc.
VS0140.25A
In Commercial Distribution

  • B384VS014025A5 ()
  • B384VS014025A1 ()

  • Needle Gauge: 25 Gauge
VS0140.25A

  • Ophthalmic laser system beam guide
23ga Bending Laser Probe - Iridex Compatible
Vortex Surgical, Inc.
VS0140.23I
In Commercial Distribution

  • B384VS014023I5 ()
  • B384VS014023I1 ()

  • Needle Gauge: 23 Gauge
VS0140.23I

  • Ophthalmic laser system beam guide
23ga Bending Laser Probe - Alcon Compatible
Vortex Surgical, Inc.
VS0140.23A
In Commercial Distribution

  • B384VS014023A5 ()
  • B384VS014023A1 ()

  • Needle Gauge: 23 Gauge
VS0140.23A

  • Ophthalmic laser system beam guide
20ga Bending Laser Probe - Alcon Compatible
Vortex Surgical, Inc.
VS0140.20A
In Commercial Distribution

  • B384VS014020A5 ()
  • B384VS014020A1 ()

  • Needle Gauge: 20 Gauge
VS0140.20A

  • Ophthalmic laser system beam guide
25ga Flexible Tapered Laser Probe - Iridex Compatible
Vortex Surgical, Inc.
VS0130.25I
In Commercial Distribution

  • B384VS013025I5 ()
  • B384VS013025I1 ()
VS0130.25I

  • Ophthalmic laser system beam guide
27ga Curved Laser Probe - Iridex Compatible
Vortex Surgical, Inc.
VS0120.27I
In Commercial Distribution

  • B384012027I5 ()
  • B384VS012027I1 ()

  • Needle Gauge: 27 Gauge
VS0120.27I

  • Ophthalmic laser system beam guide
27ga Curved Laser Probe - Alcon Compatible
Vortex Surgical, Inc.
VS0120.27A
In Commercial Distribution

  • B384VS012027A5 ()
  • B384VS012027A1 ()

  • Needle Gauge: 27 Gauge
VS0120.27A

  • Ophthalmic laser system beam guide
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