CastleLoc Pectus Bar System

GUDID 08809986482693

OB Pectus Bar - Straight

L&K BIOMED CO. ,LTD.

Funnel chest remodelling bar
Primary Device ID08809986482693
NIH Device Record Keye00a723d-a418-407e-a63c-66b903f66a8b
Commercial Distribution StatusIn Commercial Distribution
Brand NameCastleLoc Pectus Bar System
Version Model NumberOB28-0050
Company DUNS631159324
Company NameL&K BIOMED CO. ,LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809986482693 [Primary]

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809986482693]

Moist Heat or Steam Sterilization


[08809986482693]

Moist Heat or Steam Sterilization


[08809986482693]

Moist Heat or Steam Sterilization


[08809986482693]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-28
Device Publish Date2025-07-18

On-Brand Devices [CastleLoc Pectus Bar System]

08809986461728Stabilizer – Connector Nut
08809986461711CastleLoc Pectus Bar – Curved 1
08809986461704CastleLoc Pectus Bar – Curved 1
08809986461698CastleLoc Pectus Bar – Curved 1
08809986461681CastleLoc Pectus Bar – Curved 1
08809986461186Stabilizer – Connector
08809986461179CastleLoc Pectus Bar Curved 3 (with twisted both tip - CounterClockwise)
08809986461162CastleLoc Pectus Bar Curved 3 (with twisted both tip - CounterClockwise)
08809986461155CastleLoc Pectus Bar – Curved 2 (with twisted both tip-Clockwise)
08809986461148CastleLoc Pectus Bar – Curved 2 (with twisted both tip-Clockwise)
08809986461131CastleLoc Pectus Bar – Curved 1
08809986461124CastleLoc Pectus Bar – Curved 1
08809986466280CastleLoc Pectus Bar – Curved 1
08809986466273CastleLoc Pectus Bar – Curved 1
08809986466266CastleLoc Pectus Bar – Curved 1
08809986466259CastleLoc Pectus Bar – Curved 1
08809986466242CastleLoc Pectus Bar – Curved 1
08809986466235Stabilizer – Bridge 2 (type2)
08809986466228Stabilizer – Bridge 2 (type2)
08809986466211Stabilizer – Bridge 2 (type2)
08809986466204Stabilizer – Bridge 2 (type2)
08809986466198Stabilizer – Bridge 2 (type2)
08809986466181Stabilizer – Bridge 2 (type2)
08809986466174Stabilizer – Bridge 2 (type2)
08809986466167Stabilizer – Bridge 2 (type2)
08809986466150Stabilizer – Bridge 2 (type2)
08809986482204Stabilizer – Bridge 1 (type1)
08809986482181Stabilizer – Bridge 1 (type1)
08809986482167Stabilizer – Bridge 1 (type1)
08809986482143Stabilizer – Bridge 1 (type1)
08809986482129Stabilizer – Bridge 1 (type1)
08809986482112Stabilizer – Bridge 1 (type1)
08809986482105Stabilizer – Bridge 1 (type1)
08809986482099Stabilizer – Bridge 1 (type1)
08809986482082Stabilizer – Bridge 1 (type1)
08809986480002CastleLoc Pectus Bar - Straight
08809986482761OB Pectus Bar - Straight
08809986482754OB Pectus Bar - Straight
08809986482747OB Pectus Bar - Straight
08809986482730OB Pectus Bar - Straight
08809986482723OB Pectus Bar - Straight
08809986482716OB Pectus Bar - Straight
08809986482709OB Pectus Bar - Straight
08809986482693OB Pectus Bar - Straight

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