Identity
- Trade Name
- MobiCath™ FDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Device Name
- MobiCath BiDirectional Guiding Sheath, Large Curve FDA UDI
- Model / Reference
- D140011 FDA UDI
- Description
- MobiCath BiDirectional Guiding Sheath, Large Curve FDA UDI
Identifiers
- Catalog Number
- D140011 FDA UDI
- Primary DI / UDI-DI
- 00846835012371 FDA UDI
- FDA Product Code
- DYB FDA UDI
- GMDN Term
- Vascular guide-catheter, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1340 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 180 Centimeter FDA UDILength — 91.8 Centimeter FDA UDILength — 72 Centimeter FDA UDILength — 3.81 Centimeter FDA UDIAngle — 150 degree FDA UDILumen/Inner Diameter — .0812 Centimeter FDA UDILength — 96.4 Centimeter FDA UDILumen/Inner Diameter — 0.282 Centimeter FDA UDI
Category: Vascular guide-catheter, single-use
MobiCath™ by Greatbatch Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Vascular guide-catheter, single-use.
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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
- Greatbatch Ltd
Sources (1)
- FDA UDI 7ab99ae2-4241-4126-8988-082f6568a061 36 fields · synced Jun 8, 2026