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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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Model 2200A-47E Maestro Anterior Lead - 00857334004286

The Model 2200A-47E Anterior Lead is provided sterile for implantation. It is a flexible lead that contains bipolar platinum/iridium tip and ring electrodes with an insulated lead body. Electrical current is delivered to the tip electrode which is implanted to be in contact with the anterior trunk of the vagus nerve to block nerve signals. The ring electrode is placed in contact with the stomach to measure lead impedance. Sutures are used to anchor and stabilize the lead placement. The lead is connected to the implanted Rechargeable Neuroregulator.
Reshape Lifesciences Inc.
2200A-47E
Not in Commercial Distribution

  • 00857334004286 ()

  • Length: 47 Centimeter
2200A-47E

  • Vagus nerve electrical stimulation system lead

Paired VNS - 10810041430080

Lead, 3 mm cuff
Microtransponder
3000
In Commercial Distribution

  • 10810041430080 ()


  • Vagus nerve electrical stimulation system lead

Paired VNS - 10810041430066

Lead, 2 mm cuff
Microtransponder
3000
In Commercial Distribution

  • 10810041430066 ()


  • Vagus nerve electrical stimulation system lead

PyloPlus+ Urea Breath Test Kit - 00860001810325

No Description
Arj Medical, Inc.
PPUBTK
In Commercial Distribution

  • 00860001810325 ()


  • Carbon isotope breath test kit IVD

13C-Spirulina GEBT - M763K0211

13C-Spirulina Gastric Emptying Breath Test (GEBT)
ADVANCED BREATH DIAGNOSTICS, LLC
K021
In Commercial Distribution

  • M763K0211 ()


  • Carbon isotope breath test kit IVD

PRESTIGE® LP Cervical Disc System - 00613994490728

PUNCH 6972426 RAIL
MEDTRONIC SOFAMOR DANEK, INC.
6972426
In Commercial Distribution

  • 00613994490728 ()


  • Bone-resection orthopaedic reamer, reusable

PRESTIGE® LP Cervical Disc System - 00613994490704

PUNCH 6972446 RAIL
MEDTRONIC SOFAMOR DANEK, INC.
6972446
In Commercial Distribution

  • 00613994490704 ()


  • Bone-resection orthopaedic reamer, reusable

PRESTIGE® LP Cervical Disc System - 00613994490650

PUNCH 6972467 RAIL
MEDTRONIC SOFAMOR DANEK, INC.
6972467
In Commercial Distribution

  • 00613994490650 ()


  • Bone-resection orthopaedic reamer, reusable

PRESTIGE® LP Cervical Disc System - 00613994490636

PUNCH 6972486 RAIL
MEDTRONIC SOFAMOR DANEK, INC.
6972486
In Commercial Distribution

  • 00613994490636 ()


  • Bone-resection orthopaedic reamer, reusable

PRESTIGE® LP Cervical Disc System - 00613994490629

PUNCH 6972487 RAIL
MEDTRONIC SOFAMOR DANEK, INC.
6972487
In Commercial Distribution

  • 00613994490629 ()


  • Bone-resection orthopaedic reamer, reusable
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