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MollRing Cutter Transection Device

FDA UDI

Class II (US FDA UDI)

by LeMaitre Vascular, Inc.

Identity

Trade Name
MollRing Cutter Transection Device FDA UDI
Generic Name
Intraluminal artery stripper, reusable FDA UDI
Device Name
MollRing Cutter Transection Device, 10mm FDA UDI
Model / Reference
4200-45 FDA UDI
Description
MollRing Cutter Transection Device, 10mm FDA UDI

Identifiers

Catalog Number
4200-45 FDA UDI
Primary DI / UDI-DI
00840663102747 FDA UDI
510(k) Number
K950813 FDA UDI
FDA Product Code
DWX FDA UDI
GMDN Term
Intraluminal artery stripper, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4875 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

Category: Intraluminal artery stripper, reusable

MollRing Cutter Transection Device by LeMaitre Vascular, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intraluminal artery stripper, reusable.

Cleared under the same submission

K950813 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
LeMaitre Vascular, Inc.

Sources (1)

  • FDA UDI cb9a7448-17b6-4a7f-a9df-f80eda49e36d 36 fields · synced Jun 9, 2026