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2 Linking Screws

FDA UDI

Class II (US FDA UDI)

by Sooil Development Co., Ltd

Identity

Trade Name
2 Linking Screws FDA UDI
Generic Name
Ambulatory insulin infusion pump, electronic FDA UDI
Device Name
The linking screw is an accessory for insulin pump use. The role is to change the rotary motion of the motor in insulin pump to rectilinear motion of plunger in insulin syringe reservoir. FDA UDI
Model / Reference
Linking screw FDA UDI
Description
The linking screw is an accessory for insulin pump use. The role is to change the rotary motion of the motor in insulin pump to rectilinear motion of plunger in insulin syringe reservoir. FDA UDI

Identifiers

Primary DI / UDI-DI
08809220581007 FDA UDI
510(k) Number
K063126 FDA UDI
FDA Product Code
LGZ FDA UDI
GMDN Term
Ambulatory insulin infusion pump, electronic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5725 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

2 Linking Screws by Sooil Development Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K063126 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sooil Development Co., Ltd

Sources (1)

  • FDA UDI 11226483-3d5d-4239-a26f-d2d44d9fbd2f 35 fields · synced May 30, 2026