← Back to catalogue

Lithotripsy Probe 1.9FR 250cm

FDA UDI

Class II (US FDA UDI)

by Northgate Technologies Inc.

Identity

Trade Name
Lithotripsy Probe 1.9FR 250cm FDA UDI
Generic Name
Electrohydraulic/pneumatic lithotripsy system probe, salivary, single-use FDA UDI
Device Name
1.9FR 250cm Lithotripsy Probe for use with Autolith Touch Lithotripters FDA UDI
Model / Reference
9-202-2501 FDA UDI
Description
1.9FR 250cm Lithotripsy Probe for use with Autolith Touch Lithotripters FDA UDI

Identifiers

Primary DI / UDI-DI
00817183020059 FDA UDI
510(k) Number
K130368 FDA UDI
FDA Product Code
FFK FDA UDI
GMDN Term
Electrohydraulic/pneumatic lithotripsy system probe, salivary, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.4480 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

Yes

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: Electrohydraulic/pneumatic lithotripsy system probe, salivary, single-use

Lithotripsy Probe 1.9FR 250cm by Northgate Technologies Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrohydraulic/pneumatic lithotripsy system probe, salivary, single-use.

Cleared under the same submission

K130368 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
Northgate Technologies Inc.

Sources (1)

  • FDA UDI 527f1556-d159-4a5d-bc97-99e8cc5efac3 34 fields · synced May 30, 2026