Identity
- Trade Name
- Greatbatch Steerable Sheath FDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Device Name
- Steerable Sheath, 8 French FDA UDI
- Model / Reference
- 10876-001 FDA UDI
- Description
- Steerable Sheath, 8 French FDA UDI
Identifiers
- Catalog Number
- 10876-001 FDA UDI
- Primary DI / UDI-DI
- 00821329000416 FDA UDI
- FDA Product Code
- DQY FDA UDI
- GMDN Term
- Vascular guide-catheter, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 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
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 86 Centimeter FDA UDIOuter Diameter — 2.8 Millimeter FDA UDILumen/Inner Diameter — 0.9 Millimeter FDA UDIOuter Diameter — 3.8 Millimeter FDA UDILumen/Inner Diameter — 2.5 Millimeter FDA UDILength — 67 Centimeter FDA UDIAngle — 180 degree FDA UDI
Category: Vascular guide-catheter, single-use
Greatbatch Steerable Sheath 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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- Mach1™ — Boston Scientific · Class II
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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 408b29d2-f1ec-4f85-9dd5-bb4166508ffd 35 fields · synced Jun 8, 2026