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InvisiShunt

FDA UDI

Class II (US FDA UDI)

by Longeviti Neuro Solutions

Identity

Trade Name
InvisiShunt FDA UDI
Generic Name
Polyethylene craniofacial tissue reconstructive material FDA UDI
Device Name
OP-1001 InvisiShunt Implant FDA UDI
Model / Reference
OP1001 FDA UDI
Description
OP-1001 InvisiShunt Implant FDA UDI

Identifiers

Primary DI / UDI-DI
00855113008319 FDA UDI
510(k) Number
K211514 FDA UDI
FDA Product Code
KKY FDA UDI
GMDN Term
Polyethylene craniofacial tissue reconstructive material FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.3500 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

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

Category: Polyethylene craniofacial tissue reconstructive material

InvisiShunt by Longeviti Neuro Solutions — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polyethylene craniofacial tissue reconstructive material.

Cleared under the same submission

K211514 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Longeviti Neuro Solutions

Sources (1)

  • FDA UDI e2116faa-d10b-4bcc-891e-bd56da7953c9 34 fields · synced May 31, 2026