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Silktoe – 35 L

EUDAMEDFDA UDI

Class III (EU MDR)

Ref BRDNEWP3535L

by BRM Extremities S.r.l.

Identity

Trade Name
SILKTOE – 35 L EUDAMED
Silktoe Spacer FDA UDI
Generic Name
Total metatarsophalangeal joint prosthesis, one-piece FDA UDI
Device Name
Protesi articolari Silktoe EUDAMED
Model / Reference
BRDNEWP3535L EUDAMED
SIZE 35 LEFT FDA UDI

Identifiers

Catalog Number
BRDNEWP3535L FDA UDI
Primary DI / UDI-DI
08057717550849 EUDAMEDFDA UDI
Basic UDI-DI
805771755FT03FV EUDAMED
510(k) Number
K191966 FDA UDI
FDA Product Code
KWH FDA UDI
EMDN Code
P090604 FOOT PROSTHESES METATARSALPHALANGEAL COMPONENTS EUDAMED
GMDN Term
Total metatarsophalangeal joint prosthesis, one-piece FDA UDI

Classification

Device Class
Class III EUDAMED
Class II FDA UDI
Regulation Number
888.3720 FDA UDI
Market of Registration
Italy EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

No

FDA UDI

Silktoe – 35 L by BRM Extremities S.r.l. — Class III — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
BRM Extremities S.r.l.
EUDAMED SRN
IT-MF-000016087

Sources (2)

  • EUDAMED 7cb9d3c2-fbf9-4de4-810b-efbbf8f86071 61 fields · synced Jun 19, 2026
  • FDA UDI 2a9220b6-93cd-40ea-a582-57aee862bb1d 37 fields · synced May 30, 2026