Scanlan® VASCU-STATT® II Plus s-use bulldog clamp w/firm press Gentle-Jaw™

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref 1001-575B

by Scanlan International Inc

Identity

Trade Name: Scanlan® VASCU-STATT® II Plus s-use bulldog clamp w/firm press Gentle-Jaw™ FDA UDI
Generic Name: Surgical bulldog clamp, single-use FDA UDI
Device Name: Scanlan® VASCU-STATT® II Plus s-use bulldog clamp w/firm press Gentle- EUDAMED
Scanlan® VASCU-STATT® II Plus s-use bulldog clamp w/firm press Gentle-Jaw™- Maxi Angled 45° (orange), clamping press 165-175g, bulk NS, 10 per pk FDA UDI
Model / Reference: 1001-575B EUDAMEDFDA UDI
Description: Scanlan® VASCU-STATT® II Plus s-use bulldog clamp w/firm press Gentle-Jaw™- Maxi Angled 45° (orange), clamping press 165-175g, bulk NS, 10 per pk FDA UDI

Identifiers

Catalog Number: 1001-575B FDA UDI
Primary DI / UDI-DI: 00846159025637 EUDAMEDFDA UDI
Basic UDI-DI: B-00846159025637 EUDAMED
FDA Product Code: GDJ FDA UDI
EMDN Code: C0699 CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
GMDN Term: Surgical bulldog clamp, single-use FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Market of Registration: Netherlands EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

Category: Surgical bulldog clamp, single-use

Scanlan® VASCU-STATT® II Plus s-use bulldog clamp w/firm press Gentle-Jaw™ by Scanlan International Inc — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED

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Also classified as Surgical bulldog clamp, single-use.

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class I	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Scanlan International Inc

Sources (2)

FDA UDI 3055bae5-ef41-46cd-9b23-9201661eb40f 35 fields · synced Oct 5, 2026
EUDAMED de39a2e6-b91c-46ca-8c99-3575080e5925 61 fields · synced Oct 5, 2026