RapidSorb

Basic Information

• Brand Name: RapidSorb
• Primary DI: 10887587061597
• Version / Model: 805.520.01S
• Catalog Number: 80552001S
• Company Name: Synthes GmbH
• Labeler DUNS: 486711679
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-07
• Public Version: 4
• Public Version Date: 2022-04-25
• Public Version Status: Update
• Public Device Record Key: 62363352-af99-4ffa-bc1f-3d3f63808061

Device Description

RAPIDSORB IPS 1.5MM FASTENER CARTRIDGE/LARGE-STERILE

Device Characteristics

• Single Use: Yes
• 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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HBW	FASTENER, PLATE, CRANIOPLASTY	Neurology	882.5360	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46639	Craniofacial bone tack, bioabsorbable	A small, sterile, bioabsorbable, cylindrical shaft, typically with a flat, rounded head at one end and tapered to a point at the other, intended to be implanted into craniofacial bone (includes maxilla and/or mandible) to provide stabilization for fracture repair and reconstructive procedures, or to maintain the relative position of bony fragments, bone grafts, or bone graft substitutes. It is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., a degradable polymer), and may be designed to be heated during implantation, with a dedicated inserter, to facilitate its moulding and optimal insertion.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H98080552001S0	HIBCC
Primary	10887587061597	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K141385	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -55 – 40 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Protect from heat and radio- active sources