Biodesign

Basic Information

• Brand Name: Biodesign
• Primary DI: 00827002347892
• Version / Model: G34789
• Catalog Number: C-NRC-1.0X2.0
• 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: 5
• Public Version Date: 2023-10-04
• Public Version Status: Update
• Public Device Record Key: 01b63169-1620-4bb7-bf97-c6b6187fcdd3
• Distribution End Date: 2017-01-30

Device Description

Biodesign Nipple Reconstruction Cylinder

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
FTM	Mesh, surgical	General, Plastic Surgery	878.3300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60907	Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial	A bioabsorbable, implantable material (e.g., flat sheet) made from animal-derived collagen intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]; some types may also be intended for use as a short-term scaffold for tissue regeneration. It is constructed of collagen, which might be cross-linked (e.g., with glutaraldehyde); it does not include antimicrobial agents/materials. Disposable devices associated with implantation may be supplied with the mesh.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00827002347892	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K110402	000

Storage Conditions

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