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Stone Center Silhouette

FDA UDI

Class II (US FDA UDI)

by Applied Medical Resources Corp.

Identity

Trade Name
STONE CENTER SILHOUETTE FDA UDI
Generic Name
Polymeric ureteral stent FDA UDI
Device Name
Kit Contains: B3827, SIL MUL-LGTH COMFORT 4.6Fx22-30CM B8134, UROWIRE 1/BX FDA UDI
Model / Reference
BS129 FDA UDI
Description
Kit Contains: B3827, SIL MUL-LGTH COMFORT 4.6Fx22-30CM B8134, UROWIRE 1/BX FDA UDI

Identifiers

Primary DI / UDI-DI
30607915123759 FDA UDI
FDA Product Code
KNY FDA UDI
EZB FDA UDI
FAD FDA UDI
GMDN Term
Polymeric ureteral stent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5130 FDA UDI
876.4620 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

No

FDA UDI

Stone Center Silhouette by Applied Medical Resources Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Applied Medical Resources Corp.

Sources (1)

  • FDA UDI 81b6d31b-638e-4fc0-9b95-c096f5107343 35 fields · synced Jun 8, 2026