Biodesign

Basic Information

• Brand Name: Biodesign
• Primary DI: 00827002506565
• Version / Model: G50656
• Catalog Number: C-SLRA-GIA30
• Company Name: COOK BIOTECH INCORPORATED
• Labeler DUNS: 945385862
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-11-03
• Public Version: 4
• Public Version Date: 2021-07-30
• Public Version Status: Update
• Public Device Record Key: 9ed92fd7-8726-4772-8014-b6a6413e6aca
• Distribution End Date: 2021-07-29

Device Description

Biodesign Staple Line Reinforcement

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
OXE	Mesh, surgical, collagen, staple line reinforcement	General, Plastic Surgery	878.3300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47818	Staple line-reinforcement strip	A sterile bioabsorbable device made of material derived from animal tissue intended to buttress staple lines and control leaks of blood, fluids, and air from around staple lines typically during cardiothoracic and abdominal surgeries. It is typically available as strips of material provided with an adhesive hydrogel to facilitate rehydration of the strips and their temporary adherence to the stapler loader unit before application of the staples with the strips to the tissue. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00827002506565	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K070405	000
K170945	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in clean, dry location at room temperature
• Type: Storage Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius