FDA.reportPublic FDA data

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

Primary DI
00846159028522
Brand
Scanlan® VASCU-STATT® II approximator single-use bulldog clamp w/firmr pres
Company
SCANLAN INTERNATIONAL INC
Model
1001-541B
Catalog number
1001-541B
Device description
Scanlan® VASCU-STATT® II single-use bulldog clamp w/firmer clamping press - Mini Angled 45° (green), clamping pressure 20-25 g (BNS, 10 per pk)
Published
2017-07-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00846159028522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846159028522008461590285228461590285220846159028522

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
Radiation Sterilization

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
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00846159039931SCANLAN® ScissorsQ2423-7Q2423-72026-05-28
00846159039948SCANLAN® ScissorsQ2428-7Q2428-72026-05-28
00846159039955SCANLAN® ScissorsQ2429-7Q2429-72026-05-28
00846159039962SCANLAN® ScissorsQ2430-7Q2430-72026-05-28
00846159039979SCANLAN® ScissorsQ247-7Q247-72026-05-28
00846159039986SCANLAN® ScissorsQ25010-7Q25010-72026-05-28
00846159039993SCANLAN® ScissorsQ26044-7Q26044-72026-05-28
00846159040005SCANLAN® ScissorsQ27010-7Q27010-72026-05-28
00846159040012SCANLAN® ScissorsQ27065-7Q27065-72026-05-28
00846159040029SCANLAN® ScissorsQ27079-7NQ27079-7N2026-05-28
00846159040036SCANLAN® ScissorsQ27082-7NQ27082-7N2026-05-28
00846159040043SCANLAN® ScissorsQ27119-7Q27119-72026-05-28
00846159040050SCANLAN® ScissorsQ28032-7Q28032-72026-05-28
00846159040067SCANLAN® ScissorsQ28080-7Q28080-72026-05-28
00846159040074SCANLAN® ScissorsQ28097-7Q28097-72026-05-28
00846159040081SCANLAN® ScissorsQ28119-9Q28119-92026-05-28
00846159040098SCANLAN® ScissorsQ29092-9Q29092-92026-05-28
00846159040104SCANLAN® ScissorsQ32034-7NQ32034-7N2026-05-28
00846159040111SCANLAN® ScissorsQ32035-7NQ32035-7N2026-05-28
00846159040128SCANLAN® ScissorsQ33032-7NQ33032-7N2026-05-28

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Primary DI, Brand, Company table
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ESOT002462NAS & T AGGDJ2022-09-15
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