Ambler Surgical

Basic Information

• Brand Name: Ambler Surgical
• Primary DI: 00190660012823
• Version / Model: 17-140
• Catalog Number: 17-140
• Company Name: AMBLER SURGICAL CORP.
• Labeler DUNS: 015272206
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-29
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 64fb9049-1eb2-488b-8226-54d95b7d6d28

Device Description

Castaneda multi-purpose clamp, 5", curved shanks, angled 30º, 3.5cm long serrated jaws, ring handle

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXC	CLAMP, VASCULAR	Cardiovascular	870.4450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
15881	Neonatal/paediatric vascular clamp	A hand-held manual surgical instrument designed to compress a blood vessel (a vein or an artery) during neonatal/paediatric surgery for haemostasis (arrest or prevention of bleeding). It typically has a self-retaining, scissors-like design with ring handles and very delicate blades at the working end. It is made of high-grade stainless steel and may utilize inserts made of various materials (e.g., carbide). It is available in various sizes and the blades at the working end can have a wide variety of designs (e.g., curved, angled, semicircular) specific to different applications (e.g., for small vessels, anastomoses, aorta). This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190660012823	GS1

Customer Contacts

• Phone: [phone] ext. 0
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K092544	000