Scanlan® VASCU-STATT® approximator single-use bulldog clamp

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref 1001-507BRef 1001-509Ref 1001-510BRef 1001-511BRef 1001-507Ref 1001-509BRef 1001-512BRef 1001-510Ref 1001-511Ref 1001-508B

by Scanlan International Inc

Identity

Trade Name: Scanlan® VASCU-STATT® approximator single-use bulldog clamp FDA UDI
Generic Name: Surgical bulldog clamp, single-use FDA UDI
Device Name: Scanlan® VASCU-STATT® approximator single-use bulldog clamp EUDAMED
Scanlan® VASCU-STATT® approximator single-use bulldog clamp - Mini Straight (red), clamping pressure 10-15 g (1/sterile pkg) FDA UDI
Scanlan® VASCU-STATT® approximator single-use bulldog clamp - Mini Straight (red), clamping pressure 10-15 g (BNS, 10 per pk) FDA UDI
Scanlan® VASCU-STATT® approximator single-use bulldog clamp - Maxi Angled 45° (blue), clamping pressure 50-60 g (BNS, 10 per pk) FDA UDI
Scanlan® VASCU-STATT® approximator single-use bulldog clamp - Mini Angled 45° (red), clamping pressure 10-15 g (BNS, 10 per pk) FDA UDI
Scanlan® VASCU-STATT® approximator single-use bulldog clamp - Midi Angled 45° (white), clamping pressure 25-30 g (1/sterile pkg) FDA UDI
Scanlan® VASCU-STATT® approximator single-use bulldog clamp - Midi Straight (white), clamping pressure 25-30 g (1/sterile pkg) FDA UDI
Scanlan® VASCU-STATT® approximator single-use bulldog clamp - Midi Straight (white), clamping pressure 25-30 g (BNS, 10 per pk) FDA UDI
Scanlan® VASCU-STATT® approximator single-use bulldog clamp - Maxi Straight (blue), clamping pressure 50-60 g (1/sterile pkg) FDA UDI
Scanlan® VASCU-STATT® approximator single-use bulldog clamp - Maxi Straight (blue), clamping pressure 50-60 g (BNS, 10 per pk) FDA UDI
Model / Reference: 1001-507 EUDAMEDFDA UDI
1001-507B EUDAMEDFDA UDI
1001-512B EUDAMEDFDA UDI
1001-508B EUDAMEDFDA UDI
1001-510B EUDAMEDFDA UDI
1001-510 EUDAMEDFDA UDI
1001-509 EUDAMEDFDA UDI
1001-509B EUDAMEDFDA UDI
1001-511 EUDAMEDFDA UDI
1001-511B EUDAMEDFDA UDI
Description: Scanlan® VASCU-STATT® approximator single-use bulldog clamp - Mini Straight (red), clamping pressure 10-15 g (1/sterile pkg) FDA UDI
Scanlan® VASCU-STATT® approximator single-use bulldog clamp - Mini Straight (red), clamping pressure 10-15 g (BNS, 10 per pk) FDA UDI
Scanlan® VASCU-STATT® approximator single-use bulldog clamp - Maxi Angled 45° (blue), clamping pressure 50-60 g (BNS, 10 per pk) FDA UDI
Scanlan® VASCU-STATT® approximator single-use bulldog clamp - Mini Angled 45° (red), clamping pressure 10-15 g (BNS, 10 per pk) FDA UDI
Scanlan® VASCU-STATT® approximator single-use bulldog clamp - Midi Angled 45° (white), clamping pressure 25-30 g (1/sterile pkg) FDA UDI
Scanlan® VASCU-STATT® approximator single-use bulldog clamp - Midi Straight (white), clamping pressure 25-30 g (1/sterile pkg) FDA UDI
Scanlan® VASCU-STATT® approximator single-use bulldog clamp - Midi Straight (white), clamping pressure 25-30 g (BNS, 10 per pk) FDA UDI
Scanlan® VASCU-STATT® approximator single-use bulldog clamp - Maxi Straight (blue), clamping pressure 50-60 g (1/sterile pkg) FDA UDI
Scanlan® VASCU-STATT® approximator single-use bulldog clamp - Maxi Straight (blue), clamping pressure 50-60 g (BNS, 10 per pk) FDA UDI

Identifiers

Catalog Number: 1001-507 FDA UDI
1001-507B FDA UDI
1001-512B FDA UDI
1001-508B FDA UDI
1001-510B FDA UDI
1001-510 FDA UDI
1001-509 FDA UDI
1001-509B FDA UDI
1001-511 FDA UDI
1001-511B FDA UDI
Primary DI / UDI-DI: 00846159000061 EUDAMEDFDA UDI
00846159028461 EUDAMEDFDA UDI
00846159028645 EUDAMEDFDA UDI
00846159028485 EUDAMEDFDA UDI
00846159028560 EUDAMEDFDA UDI
00846159000535 EUDAMEDFDA UDI
00846159000528 EUDAMEDFDA UDI
00846159028546 EUDAMEDFDA UDI
00846159000542 EUDAMEDFDA UDI
00846159028621 EUDAMEDFDA UDI
Basic UDI-DI: B-00846159028461 EUDAMED
B-00846159000528 EUDAMED
B-00846159028560 EUDAMED
B-00846159028621 EUDAMED
B-00846159000061 EUDAMED
B-00846159028546 EUDAMED
B-00846159028645 EUDAMED
B-00846159000535 EUDAMED
B-00846159000542 EUDAMED
B-00846159028485 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® approximator single-use bulldog clamp by Scanlan International Inc — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED

Similar devices

Also classified as Surgical bulldog clamp, single-use.

KİNG — İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş. · Class III
Vascular Tourniquet Set, 1 Snare, 5 Tubes — DİSPOSET TIBBİ ÜRÜNLER SANAYİ VE TİCARET ANONİM ŞİRKETİ · Class IIa
Wexler Surgical, Inc. — Wexler Surgical, Inc. · Class I
BM-BID-I30C — BrosMed Medical Co., Ltd. · Class I
Sterile Vascular Silicone Ties — BATRIK MEDICAL MANUFACTURING INC. · Class IIa
BM-BID-I30P — BrosMed Medical Co., Ltd. · Class I
Sterile Vascular Silicone Ties — BATRIK MEDICAL MANUFACTURING INC. · Class IIa
Sterile Vascular Silicone Ties — BATRIK MEDICAL MANUFACTURING INC. · Class IIa

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Scanlan International Inc

Sources (20)

FDA UDI faf877a7-f294-4864-ae19-ca720e3172c8 35 fields · synced Oct 6, 2026
FDA UDI 550cddbd-1bd6-4539-8a50-3def5e9922ea 35 fields · synced May 30, 2026
FDA UDI da2dffbf-4e55-40ba-a521-31160fd90d30 35 fields · synced May 30, 2026
FDA UDI 668ee87d-2f7d-4911-8a15-5cd3f4991625 35 fields · synced May 30, 2026
FDA UDI e092f43a-2b35-4538-8fe1-ae4afda4c155 35 fields · synced May 30, 2026
FDA UDI 41569862-d145-4907-aff0-6a3a75abbe91 35 fields · synced May 30, 2026
FDA UDI 28f33075-e127-40dc-b3d5-e904f9fd0314 35 fields · synced May 30, 2026
FDA UDI e4ff3d87-462c-47f3-94b9-3c3f4eccea47 35 fields · synced May 30, 2026
FDA UDI 1601aa6d-ed85-4e98-b15e-ebe19c7ec08c 35 fields · synced May 30, 2026
FDA UDI c85129cb-02c4-4889-a076-c35a4e289797 35 fields · synced May 30, 2026
EUDAMED 8dee72d3-43d9-49cc-a652-0da596e316fa 61 fields · synced Jul 9, 2026
EUDAMED c552af54-2340-493f-b12e-b9063430d25f 61 fields · synced Jul 13, 2026
EUDAMED 75745fbf-619c-4b39-b953-0d7e4818b8d7 61 fields · synced Jul 14, 2026
EUDAMED d3b765ea-c1e6-4282-a023-cfaaef8e7379 61 fields · synced Jul 16, 2026
EUDAMED 0116c7c2-1592-4011-a0b0-404c72f52ca2 61 fields · synced Jul 17, 2026
EUDAMED fbea04af-1029-452e-bec8-b2b21e8c1520 61 fields · synced Jul 24, 2026
EUDAMED 244589c4-2f3d-4b8c-9660-2951f00dfd0a 61 fields · synced Jul 25, 2026
EUDAMED fbd6cb12-8325-4ef3-8af9-b35e807e2986 61 fields · synced Jul 26, 2026
EUDAMED a15097c1-be37-41ab-9492-9990a4ec76d1 61 fields · synced Jul 29, 2026
EUDAMED 4d10aa0b-86a9-44ce-8c35-93a5dc8d9013 61 fields · synced Sep 18, 2026