Identity
- Trade Name
- OptiSeal™ FDA UDI
- Generic Name
- Vascular catheter introduction set, nonimplantable FDA UDI
- Device Name
- Valved Peelable PTFE Introducer FDA UDI
- Model / Reference
- 1000093-017 FDA UDI
- Description
- Valved Peelable PTFE Introducer FDA UDI
Identifiers
- Catalog Number
- 7442 FDA UDI
- Primary DI / UDI-DI
- 00821329001680 FDA UDI
- FDA Product Code
- DYB 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
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Catheter Gauge — 8 French FDA UDITotal Volume — 12 Milliliter FDA UDINeedle Gauge — 18 Gauge FDA UDILength — 60 Centimeter FDA UDIOuter Diameter — .89 Millimeter FDA UDILumen/Inner Diameter — 2.8 Millimeter FDA UDILength — 13 Centimeter FDA UDI
Category: Vascular catheter introduction set, nonimplantable
OptiSeal™ is a valved peelable PTFE introducer designed for percutaneous vascular access, providing safe and efficient introduction of a catheter into the vascular system. As a single-use device, it eliminates the need for reuse or replacement, reducing the risk of infection and other complications. The OptiSeal™ has been engineered to meet the specific needs of medical professionals, with features such as high-temperature handling requirements, low-pressure resistance, and a unique needle-gauge design.
Similar devices
Also classified as Vascular catheter introduction set, nonimplantable.
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Authorization Coverage (1 country)
Regulatory Authorizations
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 41d6ed8a-6751-40bb-bb77-bdd9f127f12e 36 fields · synced Jun 28, 2026