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StarFlex Percutaneous Sheath Introducer with Side Port and Hemostasis Valve
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- StarFlex Percutaneous Sheath Introducer with Side Port and Hemostasis Valve FDA UDI
- Generic Name
- Vascular catheter introduction set, nonimplantable FDA UDI
- Device Name
- StarFlex Percutaneous Sheath Introducer with Side Port and Hemostasis Valve FDA UDI
- Model / Reference
- CLI-431-05 FDA UDI
- Description
- StarFlex Percutaneous Sheath Introducer with Side Port and Hemostasis Valve FDA UDI
Identifiers
- Catalog Number
- 27511-F FDA UDI
- Primary DI / UDI-DI
- 00841268107632 FDA UDI
- FDA Product Code
- OFL FDA UDI
- GMDN Term
- Vascular catheter introduction set, nonimplantable 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 5 French FDA UDI
Category: Vascular catheter introduction set, nonimplantable
StarFlex Percutaneous Sheath Introducer with Side Port and Hemostasis Valve by Galt Medical Corp. — Class II — FDA UDI — listed in FDA GUDID
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Also classified as Vascular catheter introduction set, nonimplantable.
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- Demax — Beijing Demax Medical Technology Co., Ltd · Class II
- Demax — Beijing Demax Medical Technology Co., Ltd · Class II
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
- Galt Medical Corp.
Sources (1)
- FDA UDI 020084bb-2160-45bd-bde5-9fb5dae5c5aa 36 fields · synced May 30, 2026