FDA.report

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

Primary DI
00846159028621
Brand
Scanlan® VASCU-STATT® approximator single-use bulldog clamp
Company
SCANLAN INTERNATIONAL INC
Model
1001-511B
Catalog number
1001-511B
Device description
Scanlan® VASCU-STATT® approximator single-use bulldog clamp - Maxi Straight (blue), clamping pressure 50-60 g (BNS, 10 per pk)
Published
2017-07-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GDJClamp, Surgical, General & Plastic Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GDJClamp, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00846159028621PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00846159028621008461590286218461590286210846159028621

GMDN Terms

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
Radiation Sterilization

Contacts

PhoneEmail
651-298-0997vanderpoelw@scanlangroup.com

Regulatory Flags

DUNS number
023055619
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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