FDA.report

SCANLAN®

Primary DI
00846159004199
Brand
SCANLAN®
Company
SCANLAN INTERNATIONAL INC
Model
3795-18
Catalog number
3795-18
Device description
Heifetz™ Temporary Occlusion Clip
Published
2016-01-06
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
false

Related Records

Contact Domains

Product Codes

CodeName
DXCClamp, Vascular
GDJClamp, Surgical, General & Plastic Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
DXCClamp, VascularCardiovascular2
GDJClamp, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00846159004199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00846159004199008461590041998461590041990846159004199

GMDN Terms

TermDefinition
Bulldog clampA manual surgical instrument with heavily serrated jaws at the working end designed to grasp, join, compress or support an organ, vessel or tissue. This instrument is typically made of high-grade stainless steel and comes in two main designs: 1) a flat, pincer-like design with jaws that close to a set opening and which have serrated finger grips or opposing handles at the proximal end which, when depressed by the operator, release the clamp; or 2) a self-retaining, scissors-like design with ring handles; both may have various straight, angled or curved blades at the working end. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam 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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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