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Optisphere

FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name
OPTISPHERE FDA UDI
Generic Name
Non-neurovascular embolization plug, animal-derived FDA UDI
Device Name
OptiSphere Embolization Spheres, 100-300 Micron, 1.0ml FDA UDI
Model / Reference
IPN913223 FDA UDI
Description
OptiSphere Embolization Spheres, 100-300 Micron, 1.0ml FDA UDI

Identifiers

Catalog Number
OSL113 FDA UDI
Primary DI / UDI-DI
10841156100001 FDA UDI
FDA Product Code
KRD FDA UDI
GMDN Term
Non-neurovascular embolization plug, animal-derived FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.3300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

No

FDA UDI

Category: Non-neurovascular embolization plug, animal-derived

Optisphere by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Non-neurovascular embolization plug, animal-derived.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Teleflex Incorporated

Sources (1)

  • FDA UDI 7c7dc41d-77b7-46ad-8e17-c1884bb71a08 35 fields · synced May 29, 2026