← Back to catalogue

Salle

FDA UDI

Class II (US FDA UDI)

by Cook Incorporated

Identity

Trade Name
Salle FDA UDI
Generic Name
Nephrostomy catheter FDA UDI
Device Name
Salle Intraoperative Pyeloplasty Stent Set With 3cm Stylet FDA UDI
Model / Reference
G32773 FDA UDI
Description
Salle Intraoperative Pyeloplasty Stent Set With 3cm Stylet FDA UDI

Identifiers

Catalog Number
SIPSF-040018-59 FDA UDI
Primary DI / UDI-DI
00827002327733 FDA UDI
FDA Product Code
FAD FDA UDI
GMDN Term
Nephrostomy catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.4620 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
MRI Safety
MR Conditional FDA UDI

Category: Nephrostomy catheter

Salle by Cook Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nephrostomy catheter.

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
Cook Incorporated

Sources (1)

  • FDA UDI dcf73b70-a8d4-4a47-a233-b752d21ff6f6 36 fields · synced Jun 8, 2026