Scanlan® VASCU-STATT® II approximator single-use bulldog clamp w/firmr pres

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref 1001-544BRef 1001-540Ref 1001-540B

by Scanlan International Inc

Identity

Trade Name: Scanlan® VASCU-STATT® II approximator single-use bulldog clamp w/firmr pres FDA UDI
Generic Name: Surgical bulldog clamp, single-use FDA UDI
Device Name: Scanlan®VASCU-STATT® II approximator single-use bulldog clamp w/firmer EUDAMED
Scanlan® VASCU-STATT® II approximator single-use bulldog clamp w/firmr EUDAMED
Scanlan® VASCU-STATT® II approximator single-use bulldog clamp w/firmr pres- Mini Straight (green), clamping pressure 20-25g (1/sterile pkg) FDA UDI
Scanlan® VASCU-STATT® II single-use bulldog clamp w/firmer clamping press - Mini Straight (green), clamping pressure 20-25g (BNS, 10 per pk) FDA UDI
Scanlan® VASCU-STATT® II single-use bulldog clamp w/firmer clamping press - Maxi Straight (orange), clamping pressure 165-175 g (BNS, 10 per pk) FDA UDI
Model / Reference: 1001-540 EUDAMEDFDA UDI
1001-540B EUDAMEDFDA UDI
1001-544B EUDAMEDFDA UDI
Description: Scanlan® VASCU-STATT® II approximator single-use bulldog clamp w/firmr pres- Mini Straight (green), clamping pressure 20-25g (1/sterile pkg) FDA UDI
Scanlan® VASCU-STATT® II single-use bulldog clamp w/firmer clamping press - Mini Straight (green), clamping pressure 20-25g (BNS, 10 per pk) FDA UDI
Scanlan® VASCU-STATT® II single-use bulldog clamp w/firmer clamping press - Maxi Straight (orange), clamping pressure 165-175 g (BNS, 10 per pk) FDA UDI

Identifiers

Catalog Number: 1001-540 FDA UDI
1001-540B FDA UDI
1001-544B FDA UDI
Primary DI / UDI-DI: 00846159000122 EUDAMEDFDA UDI
00846159028508 EUDAMEDFDA UDI
00846159028669 EUDAMEDFDA UDI
Basic UDI-DI: B-00846159028669 EUDAMED
B-00846159000122 EUDAMED
B-00846159028508 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

Yes

EUDAMEDFDA UDIEUDAMEDFDA 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 approximator single-use bulldog clamp w/firmr pres 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 (6)

FDA UDI 2562e0d5-8de8-44bc-843b-2870bd67dbb1 35 fields · synced Jul 18, 2026
FDA UDI 037b9897-c16a-4ff1-ad67-8bda34acb294 35 fields · synced May 30, 2026
FDA UDI e230f7ba-089b-463a-a2a7-d171db2c8aa6 35 fields · synced May 30, 2026
EUDAMED 4c613d08-f370-478c-ac41-06314b0cc06d 61 fields · synced Jul 10, 2026
EUDAMED f90b6f30-9600-481c-adc6-233c27244492 61 fields · synced Jul 11, 2026
EUDAMED d97e24c7-9aa0-4117-a5f6-5e669416dcb3 61 fields · synced Jul 18, 2026