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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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Product Box also contains OS-SPA DI 00850391007146
ABYRX, INC.
OS-201
In Commercial Distribution

  • 00850391007153 ()
  • 00850391007023 ()


  • Bone wax, synthetic
Mini sheath, 65cm – L2 with FlexCath Cross
ACUTUS MEDICAL, INC.
012852-005
In Commercial Distribution

  • 00850027837697 ()
012852-005

  • Cardiac transseptal access set
No Description
FUJIFILM IRVINE SCIENTIFIC, INC.
91005-500ML
In Commercial Distribution

  • 00857515006160 ()

  • Total Volume: 500 Milliliter
91005

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent
Chang Medium BMC with Gentamicin
FUJIFILM IRVINE SCIENTIFIC, INC.
91004-500ML
In Commercial Distribution

  • 00857515006153 ()

  • Total Volume: 500 Milliliter
91004

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent
No Description
Merit Pharmaceutical
036319571000
In Commercial Distribution

  • 20853620005207 ()
  • 10853620005200 ()
  • 00853620005203 ()


  • Basic intravenous administration set, noninvasive
Intraoral appliance for the treatment of snoring and mild to moderate obstructive sleep apnea with patient monitoring.
RESPIRE MEDICAL HOLDINGS LLC
SPPD030US
Not in Commercial Distribution

  • 00851861007246 ()

  • Circumference: 200 Millimeter


  • Mandible-repositioning sleep-disordered breathing orthosis
Intraoral appliance for the treatment of snoring and mild to moderate obstructive sleep apnea with patient monitoring.
RESPIRE MEDICAL HOLDINGS LLC
SPPD000US
Not in Commercial Distribution

  • 00851861007222 ()

  • Circumference: 200 Millimeter


  • Mandible-repositioning sleep-disordered breathing orthosis
No Description
Synapse Biomedical, Inc.
22-0034
In Commercial Distribution

  • 00852184003458 ()


  • Percutaneous electrical stimulation lead external pulse generator cable, reusable
Oral/Nasal w/filter (50)
Ambu A/S
814320-000/50
In Commercial Distribution

  • 05707480041848 ()
  • 05707480133918 ()
814320-000/50

  • Polysomnograph
The SuperTrapeze is a high quality, commercial grade over-bed trapeze that connects to the SuperPole (floor to ceiling safety pole). The SuperTrapeze handle features two offset ladder rungs to allow for improved use of arm strength and increased comfort. Additionally, it can hook around the pole to store out of the way when not in use. The SuperTrapeze handle is intended for moderate vertical load bearing to provide sitting and standing support for people with reduced mobility. The SuperTrapeze handle is installed onto the SuperPole by securing a support arm to the pole with 3 cone point set screws. The set screws pierce into the pole and lock the support arm in place, and the spring ring is used to prevent the set screws from back-threading. The support arm has an adjustable strap that attaches to the trapeze handle. The SuperTrapeze handle is strong enough to support the user when sitting up in bed and standing. It is important to set proper height and orientation of the SuperTrapeze to optimize the user’s range of motion. The maximum user weight for this product is 300lbs / 136kgs. Note: Product is not intended to support full body weight.
Healthcraft Products Inc.
STP-S
In Commercial Distribution

  • 00689281020596 ()
02059

  • Hand rail
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