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swiftPro URT Applicator Tip

FDA UDI

Class II (US FDA UDI)

by Emblation Limited

Identity

Trade Name
swiftPro URT Applicator Tip FDA UDI
Generic Name
Intraoperative gamma radiation detection system probe cover FDA UDI
Device Name
The swiftPro URT applicator tip is provided as a single-use, non-sterile disposable tip, which is connected to the Swift® handpiece. FDA UDI
Model / Reference
SWF-AT02 FDA UDI
Description
The swiftPro URT applicator tip is provided as a single-use, non-sterile disposable tip, which is connected to the Swift® handpiece. FDA UDI

Identifiers

Catalog Number
SWF-AT02 FDA UDI
Primary DI / UDI-DI
05060652910091 FDA UDI
510(k) Number
K222388 FDA UDI
FDA Product Code
NEY FDA UDI
GMDN Term
Intraoperative gamma radiation detection system probe cover FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Intraoperative gamma radiation detection system probe cover

swiftPro URT Applicator Tip by Emblation Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intraoperative gamma radiation detection system probe cover.

Cleared under the same submission

K222388 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Emblation Limited

Sources (1)

  • FDA UDI 81d662dc-b38d-45fb-83a7-52f763f1e8ec 35 fields · synced May 30, 2026