FDA.reportPublic FDA data

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

Primary DI
00846159000603
Brand
Scanlan® VASCU-STATT® II approximator single-use bulldog clamp w/firmr pres
Company
SCANLAN INTERNATIONAL INC
Model
1001-545
Catalog number
1001-545
Device description
Scanlan® VASCU-STATT® II approximator single-use bulldog clamp w/firmr pres- Maxi Angled 45°(orange), clamping pressure 165-175 g (1/sterile pkg)
Published
2017-07-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDJClamp, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDJClamp, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846159000603PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846159000603008461590006038461590006030846159000603

GMDN Terms#

Term, Definition table
TermDefinition
Surgical bulldog clamp, single-useA sterile, hand-held manual surgical instrument designed to grasp, join, compress or support an organ, vessel or soft-tissue. It has a flat, pincer-like design with self-retaining jaws that open upon squeezing of the handles and close upon release; it is typically made of plastic. It is commonly used for vascular clamping however it is not dedicated to a specific anatomy/surgery. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
651-298-0997vanderpoelw@scanlangroup.com

Regulatory Flags#

DUNS number
023055619
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00846159036404SCANLAN® Bulldog Clamp3795-553795-552026-06-09
00846159040524SCANLAN® Retractor8008-568008-562026-06-04
00846159040531SCANLAN® Retractor8008-598008-592026-06-04
00846159040548SCANLAN® Retractor8008-608008-602026-06-04
00846159040555SCANLAN® Retractor8888-058888-052026-06-04
00846159040562SCANLAN® Retractor8888-588888-582026-06-04
00846159040579SCANLAN® Retractor8989-188989-182026-06-04
00846159040586SCANLAN® RetractorQ195Q1952026-06-04
00846159040593SCANLAN® RetractorQ219Q2192026-06-04
00846159040609SCANLAN® RetractorQ222Q2222026-06-04
00846159040616SCANLAN® RetractorQ28124-38-2NQ28124-38-2N2026-06-04
00846159040623SCANLAN® RetractorQ28124-38-3NQ28124-38-3N2026-06-04
00846159040388SCANLAN® Retractor8008-1828008-1822026-06-03
00846159040395SCANLAN® Retractor8008-2008008-2002026-06-03
00846159040401SCANLAN® Retractor8008-2028008-2022026-06-03
00846159040418SCANLAN® Retractor8008-2048008-2042026-06-03
00846159040425SCANLAN® Retractor8008-24-18008-24-12026-06-03
00846159040432SCANLAN® Retractor8008-268008-262026-06-03
00846159040449SCANLAN® Retractor8008-26-18008-26-12026-06-03
00846159040456SCANLAN® Retractor8008-26-28008-26-22026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536085651neon3Ulrich GmbH & Co. KGGDJ2026-06-08
10849771050374NAKEY SURGICAL, INC.GDJ2023-03-31
G25003048090Backhaus Towel Forceps 9cmN S SURGICAL COMPANYGDJ2023-01-31
G25003048110Backhaus Towel Forceps 11cmN S SURGICAL COMPANYGDJ2023-01-31
G25003048130Backhaus Towel Forceps 13cmN S SURGICAL COMPANYGDJ2023-01-31
10849771050381NAKEY SURGICAL, INC.GDJ2023-01-26
10849771050398NAKEY SURGICAL, INC.GDJ2023-01-26
14026704789570PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704789662PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704789679PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791160PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791177PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
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14026704791191PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791276PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791283PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791290PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791306PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791566PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791573PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791634PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
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ESOT001972NAS & T AGGDJ2022-09-15
ESOT001982NAS & T AGGDJ2022-09-15
ESOT002452NAS & T AGGDJ2022-09-15
ESOT002462NAS & T AGGDJ2022-09-15
ESOT002862NAS & T AGGDJ2022-09-15