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Lithotripsy Probe 9FR 54cm

FDA UDI

Class II (US FDA UDI)

by Northgate Technologies Inc.

Identity

Trade Name
Lithotripsy Probe 9FR 54cm FDA UDI
Generic Name
Electrohydraulic/pneumatic lithotripsy system probe, urinary, single-use FDA UDI
Device Name
9FR 54cm Lithotripsy Probe for use with Autolith Lithotripters FDA UDI
Model / Reference
9-900-54 FDA UDI
Description
9FR 54cm Lithotripsy Probe for use with Autolith Lithotripters FDA UDI

Identifiers

Primary DI / UDI-DI
00817183020172 FDA UDI
510(k) Number
K914516 FDA UDI
FDA Product Code
FFK FDA UDI
GMDN Term
Electrohydraulic/pneumatic lithotripsy system probe, urinary, 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, urinary, single-use

Lithotripsy Probe 9FR 54cm 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, urinary, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Northgate Technologies Inc.

Sources (1)

  • FDA UDI fc64fbcd-2ddb-4e0c-9901-43ba44b5ee12 34 fields · synced Jun 8, 2026