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Ram® Suturing Device Kit, 3.5mm

EUDAMEDFDA UDI

Class III (EU MDR)

Ref 021900

by LSI SOLUTIONS, Inc.

Identity

Trade Name
RAM® SUTURING DEVICE KIT, 3.5MM EUDAMED
RAM® FDA UDI
Generic Name
Suturing unit, single-use FDA UDI
Device Name
RAM® SUTURING DEVICE KIT, 3.5MM EUDAMED
RAM® DEVICE, 3.5MM FDA UDI
Model / Reference
021900 EUDAMEDFDA UDI
Description
RAM® DEVICE, 3.5MM FDA UDI

Identifiers

Catalog Number
021900 FDA UDI
Primary DI / UDI-DI
00850200006674 EUDAMEDFDA UDI
Basic UDI-DI
B-00850200006674 EUDAMED
510(k) Number
K222783 FDA UDI
FDA Product Code
DWS FDA UDI
EMDN Code
H900899 SINGLE-USE INSTRUMENTS FOR SUTURES - OTHER EUDAMED
GMDN Term
Suturing unit, single-use FDA UDI

Classification

Device Class
Class III EUDAMED
Class I FDA UDI
Regulation Number
870.4500 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

Yes

FDA UDI

Ram® Suturing Device Kit, 3.5mm by LSI Solutions, Inc. — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
LSI SOLUTIONS, Inc.
EUDAMED SRN
US-MF-000008267
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (2)

  • EUDAMED ab19a18b-1001-45b4-8665-8c0c01e88708 61 fields · synced Jul 22, 2026
  • FDA UDI 3dc10642-09be-44b1-a7c4-bcbc288ca94a 37 fields · synced May 30, 2026