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Lotus™ Introducer Set

FDA UDI

Class II (US FDA UDI)

by Creganna Unlimited Company

Identity

Trade Name
Lotus™ Introducer Set FDA UDI
Generic Name
Vascular catheter introduction set, nonimplantable FDA UDI
Device Name
Lotus™ Introducer Set, Small FDA UDI
Model / Reference
H749NTR180 FDA UDI
Description
Lotus™ Introducer Set, Small FDA UDI

Identifiers

Catalog Number
LIS-S FDA UDI
Primary DI / UDI-DI
05391526210109 FDA UDI
FDA Product Code
DYB FDA UDI
GMDN Term
Vascular catheter introduction set, nonimplantable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1340 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 47.5 Centimeter FDA UDI
Length — 30.5 Centimeter FDA UDI

Category: Vascular catheter introduction set, nonimplantable

Lotus™ Introducer Set by Creganna Unlimited Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular catheter introduction set, nonimplantable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Creganna Unlimited Company

Sources (1)

  • FDA UDI c7b1e296-90c7-47e5-9e16-d60f68fc1f14 35 fields · synced Jun 6, 2026