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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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NA - 10887587031712

SCREW PART NUMBER INSERT FOR 401.386-401.398
Synthes GmbH
304.700T35
In Commercial Distribution

  • H980304700T35 ()
  • 10887587031712 ()
304700T35

  • Surgical instrument/implant rack

NA - 10887587031620

SCREW PART NUMBER INSERT FOR 401.354-401.374
Synthes GmbH
304.700T27
In Commercial Distribution

  • H980304700T27 ()
  • 10887587031620 ()
304700T27

  • Surgical instrument/implant rack

CUFF:INFLATION FOR ROSI - 00817122020430

Part Number 200812, CUFF:INFLATION FOR ROSI
VASCULAR TECHNOLOGY, INCORPORATED
200812
In Commercial Distribution

  • 00817122020430 ()
200812

  • Surgical irrigation/aspiration pump, reusable

VTI Oxygen Analyzer - 00817122020010

Part Number 102200 VTI Oxygen Analyzer
VASCULAR TECHNOLOGY, INCORPORATED
102200
Not in Commercial Distribution

  • 00817122020010 ()
102200

  • Respiratory oxygen monitor, battery-powered

ENDURANCE - 10603295128151

ENDURANCE REVISION CASE & TRAY Number 2
DEPUY ORTHOPAEDICS, INC.
2521-60-004
In Commercial Distribution

  • 10603295128151 ()
252160004

  • Instrument tray, reusable

ENDURANCE - 10603295128144

ENDURANCE REVISION CASE & TRAY Number 1
DEPUY ORTHOPAEDICS, INC.
2521-60-003
In Commercial Distribution

  • 10603295128144 ()
252160003

  • Instrument tray, reusable

NA - 00885556023259

MDF PROXIMAL REAMER NUMBER 1 STARTER
Smith & Nephew, Inc.
71354147
Not in Commercial Distribution

  • 00885556023259 ()
71354147

  • Medullary canal orthopaedic reamer, rigid

KMEDIC - 24026704274387

RONGEUR 6 1/2" NUMBER 4A
TELEFLEX INCORPORATED
IPN014157
In Commercial Distribution

  • 24026704274387 ()
  • 04026704274383 ()

  • Length: 16.5 Centimeter
KM47275

  • Orthopaedic joint/limb rongeur

KMEDIC - 24026704274370

RONGEUR 5 1/2 NUMBER 4
TELEFLEX INCORPORATED
IPN014156
In Commercial Distribution

  • 24026704274370 ()
  • 04026704274376 ()

  • Length: 14 Centimeter
  • Curved 4 x 9MM
KM47274

  • Orthopaedic joint/limb rongeur

Apron and Vest, Men's Xtra Large, Standard Lead - 00843696130435

Apron (23" X 51-56") & Vest (27" X 27") Standard Lead, Shimmering Tan
Flow X Ray Corporation
66084-41
In Commercial Distribution

  • 00843696130435 ()


  • Radiation shielding apron

Apron and Vest, Men's Xtra Large, Standard Lead - 00843696130428

Apron (23" X 51-56") & Vest (27" X 27") Standard Lead, Shimmering Green
Flow X Ray Corporation
66084-38
In Commercial Distribution

  • 00843696130428 ()


  • Radiation shielding apron

Apron and Vest, Men's Xtra Large, Standard Lead - 00843696130411

Apron (23" X 51-56") & Vest (27" X 27") Standard Lead, Shimmering Bronze
Flow X Ray Corporation
66084-37
In Commercial Distribution

  • 00843696130411 ()


  • Radiation shielding apron

Apron and Vest, Men's Xtra Large, Standard Lead - 00843696130404

Apron (23" X 51-56") & Vest (27" X 27") Standard Lead, Hunter Green
Flow X Ray Corporation
66084-36
In Commercial Distribution

  • 00843696130404 ()


  • Radiation shielding apron

Apron and Vest, Men's Xtra Large, Standard Lead - 00843696127190

Apron (23" X 51-56") & Vest (27" X 27") Standard Lead, Paw Prints
Flow X Ray Corporation
66084-34
In Commercial Distribution

  • 00843696127190 ()


  • Radiation shielding apron

Apron and Vest, Men's Xtra Large, Standard Lead - 00843696127176

Apron (23" X 51-56") & Vest (27" X 27") Standard Lead, Navy Blue
Flow X Ray Corporation
66084-22
In Commercial Distribution

  • 00843696127176 ()


  • Radiation shielding apron

Apron and Vest, Men's Xtra Large, Standard Lead - 00843696127169

Apron (23" X 51-56") & Vest (27" X 27") Standard Lead, Royal Blue
Flow X Ray Corporation
66084-20
In Commercial Distribution

  • 00843696127169 ()


  • Radiation shielding apron

Apron and Vest, Men's Xtra Large, Standard Lead - 00843696127145

Apron (23" X 51-56") & Vest (27" X 27") Standard Lead, Medium Blue
Flow X Ray Corporation
66084-16
In Commercial Distribution

  • 00843696127145 ()


  • Radiation shielding apron

DOMREX™ PI GLOVES - 00628032222902

No Description
Domrex Pharma Inc
90
In Commercial Distribution

  • 10628032222909 ()
  • 00628032222902 ()


  • Polyisoprene surgical glove, non-powdered, non-antimicrobial

3.0T 16ch Shoulder Coil (Device) - 00856181003909

The 16ch Shoulder Coil is a receive-only phased array RF coil designed for optimum signal-to-noise ratio (SNR) and uniform coverage of the shoulder anatomy for use with GE Healthcare Magnetic Resonance Imaging (MRI) scanners. The coil receives magnetic resonance signals generated in hydrogen nuclei (protons) in the shoulder while blocking the high-frequency magnetic field applied by the MRI scanner at specified timings. The received signals are amplified before being transferred to the MRI scanner through the coil’s system cable. The amplified signals are processed into tomographic images of the shoulder anatomy by the MRI scanner. Images are typically generated as axial, sagittal, coronal oblique slices and include coverage of the Humerus, Humeral Head, Labrum, Labral Tear, Glenoid, Scapula, Clavicle, and Rotator Cuff regions of the shoulder anatomy. During a shoulder MRI exam, the patient lays in the supine position on the MRI scanner table. The rigid Posterior Array is positioned beneath the patient’s affected shoulder. The flexible Anterior Array is positioned on top of the patient’s affected shoulder. The 16ch Shoulder Posterior Housing Pad and 16ch Shoulder Pad provided with the coil promote patient comfort and facilitate patient positioning. Table Straps provided with the MRI scanner may be used to minimize unintended patient movement during the exam.
NEOCOIL, LLC
90
In Commercial Distribution

  • 00856181003909 ()
NC143202

  • MRI system coil, radio-frequency

Stoggles - 00850023503633

Stoggles peach square standard (with blue blocking + anti-fog)
Stoggles Inc.
90
In Commercial Distribution

  • 00850023503633 ()


  • Spectacle frame

BD BACTEC™ Platelet Anaerobic/F Culture Vials - 00382904420543

BD BACTEC™ Platelet Anaerobic/F Culture Vials
BECTON, DICKINSON AND COMPANY
442054
In Commercial Distribution

  • 30382904420544 ()
  • 00382904420543 ()

  • Total Volume: 40 Milliliter
442054

  • Culture medium antimicrobial supplement IVD

BD BACTEC™ Plus Aerobic/F Culture Vials - 00382904420239

BD BACTEC™ Plus Aerobic/F Medium
BECTON, DICKINSON AND COMPANY
442023
In Commercial Distribution

  • 30382904420230 ()
  • 00382904420239 ()

  • Total Volume: 30 Milliliter
442023

  • Culture medium antimicrobial supplement IVD

N/A - 20885403473200

Surgical Clipper Charging Adapter
CAREFUSION 2200, INC
5514A
In Commercial Distribution

  • 20885403473200 ()
  • 50885403473201 ()
5514A

  • Noninvasive device battery charger

N/A - 20885403473170

Surgical Clipper
CAREFUSION 2200, INC
5513E
In Commercial Distribution

  • 20885403473170 ()
  • 50885403473171 ()
5513E

  • Surgical hair clippers

LOQTEQ® - 04042409347382

LOQTEQ® Clavicle Shaft Plate 3.5, 7 holes, L 88, L
aap Implantate AG
PK 3522-07-2
In Commercial Distribution

  • 04042409347382 ()
PK 3522-07-2

  • Orthopaedic fixation plate, non-bioabsorbable

LOQTEQ® - 04042409347375

LOQTEQ® Clavicle Shaft Plate 3.5, 7 holes, L 88, R
aap Implantate AG
PK 3521-07-2
In Commercial Distribution

  • 04042409347375 ()
PK 3521-07-2

  • Orthopaedic fixation plate, non-bioabsorbable

LOQTEQ® - 04042409204722

LOQTEQ® 1/3 Tubular Plate 3.5, 7 holes, L 88
aap Implantate AG
PG 3553-07-2
In Commercial Distribution

  • 04042409204722 ()
PG 3553-07-2

  • Orthopaedic fixation plate, non-bioabsorbable

McKesson - 10612479230122

Bilateral Limb Drape 116 in x 88 in x 144 in
MCKESSON MEDICAL-SURGICAL INC.
183-i80-09138G-S
In Commercial Distribution

  • 40612479230130 ()
  • 10612479230122 ()


  • Patient surgical drape, single-use

FIBRINET - 00850014593025

The FIBRINET® System is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. The 27 mL FIBRINET® System is available as a single pack (item number 510358) or as a multipack of 5 individually packaged kits (item number 510358-5). The 27 mL FIBRINET® System contains 3 blood collection tubes with yellow stoppers containing buffered sodium citrate solution anticoagulant and plasma separator gel for preparing PRP, 1 PRFM tube containing calcium chloride solution with red stopper, one 30 mL membrane vial with closure containing calcium chloride solution, 1 latex free disposable tourniquet, 2 BD Vacutainer® Luer-Lok™ access devices, 1 BD Vacutainer® blood collection set with Safety-Lok® needle and 12" tubing preassembled, 2 BD Vacutainer® Blood transfer devices, and 1 vial adapter.
ROYAL BIOLOGICS INC.
PRFMK
In Commercial Distribution


  • Total Volume: 27 Milliliter
510358

  • Haematological concentrate system preparation kit, platelet concentration

FIBRINET - 10850014593022

The FIBRINET® System is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. The 27 mL FIBRINET® System is available as a single pack (item number 510358) or as a multipack of 5 individually packaged kits (item number 510358-5). The 27 mL FIBRINET® System contains 3 blood collection tubes with yellow stoppers containing buffered sodium citrate solution anticoagulant and plasma separator gel for preparing PRP, 1 PRFM tube containing calcium chloride solution with red stopper, one 30 mL membrane vial with closure containing calcium chloride solution, 1 latex free disposable tourniquet, 2 BD Vacutainer® Luer-Lok™ access devices, 1 BD Vacutainer® blood collection set with Safety-Lok® needle and 12" tubing preassembled, 2 BD Vacutainer® Blood transfer devices, and 1 vial adapter.
ROYAL BIOLOGICS INC.
PRFMK
Not in Commercial Distribution

  • 30850014593019 ()
  • 10850014593022 ()
  • 10851802007073 ()

  • Total Volume: 27 Milliliter
510358

  • Haematological concentrate system preparation kit, platelet concentration
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