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Peri-Loc

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
Peri-Loc FDA UDI
Generic Name
Orthopaedic fixation plate, non-bioabsorbable, non-sterile FDA UDI
Device Name
3.5MM LAT PROX TIBIA LCK PL 4HL RT 4HL HD FDA UDI
Model / Reference
71934774 FDA UDI
Description
3.5MM LAT PROX TIBIA LCK PL 4HL RT 4HL HD FDA UDI

Identifiers

Catalog Number
71934774 FDA UDI
Primary DI / UDI-DI
00885556291443 FDA UDI
510(k) Number
K033669 FDA UDI
FDA Product Code
HRS FDA UDI
GMDN Term
Orthopaedic fixation plate, non-bioabsorbable, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Peri-Loc by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K033669 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Smith & Nephew, Inc.

Sources (1)

  • FDA UDI c26b1ad7-0cf9-42ff-ac5b-3bfe5d73d6da 37 fields · synced Jun 8, 2026