Adult Curved Sternal Latch Retractor

Basic Information

• Brand Name: Adult Curved Sternal Latch Retractor
• Primary DI: B040SRLP10
• Version / Model: SRLP-1
• Catalog Number: SRLP-1
• Company Name: GENESEE BIOMEDICAL, INC.
• Labeler DUNS: 939872651
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-04
• Public Version: 1
• Public Version Date: 2024-12-12
• Public Version Status: New
• Public Device Record Key: 6d889dba-c587-4f1a-9ed5-ba7707c62aec

Device Description

Large Patient Curved Sternal Latch Retractor with 2 sets of Blades Suitable for adult patients >90 kg or with BMI of 35 or above

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
GAD	Retractor	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46771	Sternum spreader	A self-locking surgical instrument designed to force apart the surgically-split sternum (the breastbone) to permit surgical cardiac intervention within the thoracic cavity. This device will typically have two interchangeable profiled, pivoted blades (self-adjusting their angle as the instrument is opened) at the distal end that hook over the margins of the severed sternum, and a ratchet mechanism along its horizontal bar to adjust the blades, parting the sternum and maintain its set position once it has been set. It is also known as a sternum retractor and is available in various designs and sizes. It is made of high-grade stainless steel. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B040SRLP1	HIBCC		1	Not in Commercial Distribution	2024-12-04
Primary	B040SRLP10	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]