RapidSorb

Basic Information

• Brand Name: RapidSorb
• Primary DI: 10887587064239
• Version / Model: 851.801.01S
• Catalog Number: 85180101S
• Company Name: Synthes GmbH
• Labeler DUNS: 486711679
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-14
• Public Version: 6
• Public Version Date: 2023-09-18
• Public Version Status: Update
• Public Device Record Key: 7963d9d9-35cb-4c0d-91c6-6ff3e485f3ae

Device Description

RAPID RESORBABLE CRANIAL CLAMP 18MM

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: No
• 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
GXR	COVER, BURR HOLE	Neurology	882.5250	2
HBW	FASTENER, PLATE, CRANIOPLASTY	Neurology	882.5360	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46641	Craniofacial fixation plate, bioabsorbable	A small, implantable, non-customized sheet of firm material designed to be attached with screws to craniofacial bone (including the maxilla and/or mandible) to bridge and stabilize a fracture gap or craniotomy flap, and/or cover a burr hole. It is made of bioabsorbable materials (e.g., degradable polymer) and is available in a variety of designs (e.g., Y-plate, curved plate, mesh-panel, burr hole cover). Instruments intended to facilitate implantation (e.g., driver), or bioabsorbable plate fixation implants (i.e., bone screws), may be included with the plate.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H98085180101S0	HIBCC
Primary	10887587064239	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K041611	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 41 – 77 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: High: 43 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 5 – 25 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: High: 110 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: .