SyntheCel

Basic Information

• Brand Name: SyntheCel
• Primary DI: 10887587001395
• Version / Model: SC.400.120.01S
• Catalog Number: SC40012001S
• 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: 5
• Public Version Date: 2022-04-25
• Public Version Status: Update
• Public Device Record Key: 0fae0d2f-49bf-42a0-8671-77eac70831ab

Device Description

SYNTHECEL® DURA REPAIR 10.0CM X 12.0CM(4" X5")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: MR Safe
• 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
GXQ	DURA SUBSTITUTE	Neurology	882.5910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48044	Dura mater graft, bioengineered	A sterile device made from bioengineered materials (e.g., cellulose fibres produced by microorganisms) used for the repair or replacement of the dura mater in a recipient during a neurosurgical procedure. Restoration of the dura mater maintains the integrity of the brain and spinal cord, and helps prevent leakage of the cerebrospinal fluid (CSF). This dural graft is typically overlaid on the patient's dura. It may be supplied in various sizes and shapes (e.g., square or rectangular) and may be sutured into place.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H980SC40012001S0	HIBCC
Primary	10887587001395	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K113071	000
K131792	000
K212943	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: .
• Type: Special Storage Condition, Specify
• Special Conditions: Protect from heat and radio- active sources
• Type: Handling Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 41 – 77 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 5 – 25 Degrees Celsius