RULTRACT

Basic Information

• Brand Name: RULTRACT
• Primary DI: B152410032AP0
• Version / Model: 4100-32AP
• Catalog Number: 4100-32AP
• Company Name: PEMCO INC
• Labeler DUNS: 004217071
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-06
• Public Version: 1
• Public Version Date: 2021-12-14
• Public Version Status: New
• Public Device Record Key: f779e3d1-e9a5-45a2-bf63-67345c3772c0

Device Description

Offset Top Post

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: Yes
• 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
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	870.4500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45181	Surgical retraction system, reusable	A frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during open surgery; is not intended for neurosurgery or ophthalmic surgery. It includes a mounting frame (e.g., bar, ring) and a number of detachable retracting blades, may include additional features (e.g., ratchet mechanisms, fibreoptic lights), and might be intended to be mounted to the operating table or be non-fixed. It is typically made of high-grade stainless steel and synthetic materials. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B152410032AP0	HIBCC

Customer Contacts

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