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BOEHRINGER® ViSiGi 3D™ Sleeve Gastrectomy Calibration System, size 36Fr
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- BOEHRINGER® ViSiGi 3D™ Sleeve Gastrectomy Calibration System, size 36Fr FDA UDI
- Generic Name
- Gastric calibration tube FDA UDI
- Device Name
- ViSiGi 3D® Calibration System size 36Fr Sleeve/Std FDA UDI
- Model / Reference
- 5236 FDA UDI
- Description
- ViSiGi 3D® Calibration System size 36Fr Sleeve/Std FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10816286020604 FDA UDI
- 510(k) Number
- K130483 FDA UDI
- FDA Product Code
- KNT FDA UDI
- GMDN Term
- Gastric calibration tube FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 36 French FDA UDI
Category: Gastric calibration tube
BOEHRINGER® ViSiGi 3D™ Sleeve Gastrectomy Calibration System, size 36Fr by Boehringer Laboratories, Llc — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Gastric calibration tube.
- Gastric Balloon Suction Catheter — ReShape Lifesciences Inc. · Class II
- GastriSail — Covidien LP · Class II
- ReShape Calibration Tubes™ — ReShape Lifesciences Inc. · Class II
- Gastric Balloon Suction Catheter — Apollo Endosurgery · Class II
- ReShape Calibration Tubes — ReShape Lifesciences Inc. · Class II
- Standard Bougie — Standard Bariatrics · Class II
- Endolumik — Endolumik, Inc. · Class II
- Endolumik — Endolumik, Inc. · Class II
Cleared under the same submission
K130483 also covers:
- BOEHRINGER® Accessory Bulb for ViSiGi 3D™ Sleeve Gastrectomy Calibration System — BOEHRINGER LABORATORIES, LLC
- BOEHRINGER® ViSiGi 3D® Calibration System size 32Fr Bypass/Short — BOEHRINGER LABORATORIES, LLC
- BOEHRINGER® ViSiGi 3D® Calibration System size 32Fr Bypass/Short w/bulb — BOEHRINGER LABORATORIES, LLC
- BOEHRINGER® ViSiGi 3D® Calibration System size 36Fr Bypass/Short — BOEHRINGER LABORATORIES, LLC
- BOEHRINGER® ViSiGi 3D® Calibration System size 36Fr Bypass/Short w/bulb — BOEHRINGER LABORATORIES, LLC
- BOEHRINGER® ViSiGi 3D® Calibration System size 40Fr Bypass/Short — BOEHRINGER LABORATORIES, LLC
- BOEHRINGER® ViSiGi 3D® Calibration System size 40Fr Bypass/Short w/bulb — BOEHRINGER LABORATORIES, LLC
- BOEHRINGER® ViSiGi 3D™ Calibration System for Roux-en-y, size 32Fr — BOEHRINGER LABORATORIES, LLC
- BOEHRINGER® ViSiGi 3D™ Calibration System for Roux-en-y, size 32Fr w/bulb — BOEHRINGER LABORATORIES, LLC
- BOEHRINGER® ViSiGi 3D™ Sleeve Gastrectomy Calibration System, size 36Fr w/bulb — BOEHRINGER LABORATORIES, LLC
- BOEHRINGER® ViSiGi 3D™ Sleeve Gastrectomy Calibration System, size 40Fr w/bulb — BOEHRINGER LABORATORIES, LLC
- BOEHRINGER® ViSiGi™ 3D Sleeve Gastrectomy Calibration System, size 40Fr — BOEHRINGER LABORATORIES, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Boehringer Laboratories, Llc
Sources (1)
- FDA UDI e6e26d02-5179-480d-9663-7a2e3df219a6 36 fields · synced May 30, 2026