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OptiSeal™

FDA UDI

Class II (US FDA UDI)

by Greatbatch Ltd

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
1000092-004 FDA UDI
Description
Valved Peelable PTFE Introducer FDA UDI

Identifiers

Primary DI / UDI-DI
00821329600302 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

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
Total Volume — 12 Milliliter FDA UDI
Needle Gauge — 18 Gauge FDA UDI
Length — 60 Centimeter FDA UDI
Outer Diameter — .89 Millimeter FDA UDI
Length — 13 Centimeter FDA UDI
Lumen/Inner Diameter — 3.2 Millimeter FDA UDI
Catheter Gauge — 9 French FDA UDI

Category: Vascular catheter introduction set, nonimplantable

OptiSeal™ by Greatbatch Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular catheter introduction set, nonimplantable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Greatbatch Ltd

Sources (1)

  • FDA UDI 9c74cd17-0119-47b9-9863-1c2346454460 35 fields · synced Jun 8, 2026