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BOEHRINGER® ViSiGi 3D™ Low Suction Sleeve Gastrectomy Calibration Sys, size 40Fr
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- BOEHRINGER® ViSiGi 3D™ Low Suction Sleeve Gastrectomy Calibration Sys, size 40Fr FDA UDI
- Generic Name
- Gastric calibration tube FDA UDI
- Device Name
- ViSiGi™ 3D Low Suction Sleeve Gastrectomy Calibration System, size 40Fr FDA UDI
- Model / Reference
- 5240LS FDA UDI
- Description
- ViSiGi™ 3D Low Suction Sleeve Gastrectomy Calibration System, size 40Fr FDA UDI
Identifiers
- Catalog Number
- 5240LS FDA UDI
- Primary DI / UDI-DI
- 10816286020741 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
- Not 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 — 40 French FDA UDI
BOEHRINGER® ViSiGi 3D™ Low Suction Sleeve Gastrectomy Calibration Sys, size 40Fr by Boehringer Laboratories, Llc — Class II — FDA UDI — listed in FDA GUDID
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 — 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
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 b66c72a2-f0f6-428c-967a-bc627a9dee59 38 fields · synced Jun 1, 2026