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miniRUMEL™

FDA UDI

Class I (US FDA UDI)

by LSI Solutions, Inc.

Identity

Trade Name
miniRUMEL™ FDA UDI
Generic Name
Suture/ligature tightener, single-use FDA UDI
Device Name
miniRUMEL™ DEVICE, 25cm FDA UDI
Model / Reference
080995 FDA UDI
Description
miniRUMEL™ DEVICE, 25cm FDA UDI

Identifiers

Catalog Number
080995 FDA UDI
Primary DI / UDI-DI
00850200006988 FDA UDI
FDA Product Code
DWS FDA UDI
GMDN Term
Suture/ligature tightener, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
870.4500 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

Yes

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 — 25 Centimeter FDA UDI

Category: Suture/ligature tightener, single-use

miniRUMEL™ by LSI Solutions, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Suture/ligature tightener, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
LSI Solutions, Inc.

Sources (1)

  • FDA UDI 1b776ce5-c108-4ccc-b6ab-4ee82861e6df 36 fields · synced May 30, 2026