← Back to catalogue

Speedy Flap

FDA UDI

Class II (US FDA UDI)

by Jeil Medical Corporation

Identity

Trade Name
Speedy Flap FDA UDI
Generic Name
Cranial bur hole cover FDA UDI
Model / Reference
SF-12F FDA UDI

Identifiers

Primary DI / UDI-DI
08809265156147 FDA UDI
510(k) Number
K130447 FDA UDI
FDA Product Code
GXR FDA UDI
GMDN Term
Cranial bur hole cover FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5250 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

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: Cranial bur hole cover

Speedy Flap by Jeil Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cranial bur hole cover.

Cleared under the same submission

K130447 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Jeil Medical Corporation

Sources (1)

  • FDA UDI 6ba5ed41-d7e2-41de-9aa8-10d1a3b1ca64 33 fields · synced May 30, 2026