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CastleLoc Pectus Bar System

FDA UDI

Class II (US FDA UDI)

by L&K Biomed Co. , Ltd.

Identity

Trade Name
CastleLoc Pectus Bar System FDA UDI
Generic Name
Funnel chest remodelling bar FDA UDI
Device Name
OB Pectus Bar - Straight FDA UDI
Model / Reference
OB28-0090 FDA UDI
Description
OB Pectus Bar - Straight FDA UDI

Identifiers

Primary DI / UDI-DI
08809986482778 FDA UDI
FDA Product Code
HRS FDA UDI
GMDN Term
Funnel chest remodelling bar FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Funnel chest remodelling bar

CastleLoc Pectus Bar System by L&K Biomed Co. , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Funnel chest remodelling bar.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
L&K Biomed Co. , Ltd.

Sources (1)

  • FDA UDI 8edc2d1a-63dd-4faa-a1d2-75ed6097da54 33 fields · synced May 30, 2026