Shutters 1000 units

FDA UDI

Class I (US FDA UDI)

by Plasmabiotics

Identity

Trade Name: Shutters 1000 units FDA UDI
Generic Name: Endoscope clean-storage system FDA UDI
Device Name: Shutters 1000 units FDA UDI
Model / Reference: OBag FDA UDI
Description: Shutters 1000 units FDA UDI

Identifiers

Primary DI / UDI-DI: 03701354404304 FDA UDI
FDA Product Code: LXG FDA UDI
GMDN Term: Endoscope clean-storage system FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.2050 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 20 Centimeter FDA UDI
Width — 12 Centimeter FDA UDI
Height — 3 Centimeter FDA UDI

Category: Endoscope clean-storage system

Shutters 1000 units by Plasmabiotics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Plasmabiotics

Sources (1)

FDA UDI 3488bece-cc56-4ee2-b489-1cc6d518d2af 35 fields · synced May 30, 2026