BIOBRANE

Basic Information

• Brand Name: BIOBRANE
• Primary DI: 05000223504083
• Version / Model: 66027705
• Catalog Number: 66027705
• Company Name: SMITH & NEPHEW MEDICAL LIMITED
• Labeler DUNS: 216344051
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-03
• Public Version: 2
• Public Version Date: 2025-07-21
• Public Version Status: Update
• Public Device Record Key: 8d8a33a4-5562-421d-9e53-ccafb13bf9b0

Device Description

BIOBRANE DRESSING - MEDIUM GLOVE US

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: Yes
• 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: No
• 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
KGN	Wound dressing with animal-derived material(s)	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
45023	Animal-derived wound matrix dressing	A bioabsorbable animal-derived protein matrix [e.g., peptides derived from collagen] designed to provide: 1) a matrix of structural proteins and/or 2) a skin template of living cells [fibroblasts], to facilitate the infiltration/attachment of native cells/tissues (e.g., blood vessels) for wound/skin healing. It is available in various forms [e.g., solution, powder, occlusive/semi-occlusive cover (non-oral)] and may include additional compounds (e.g., alginate, fatty acids). It may be intended to be covered with a secondary dressing. It is commonly intended for treating partial- and full-thickness wounds, ulcers, and draining, surgical, and traumatic wounds. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05000223504168	GS1	CAR	1	In Commercial Distribution
Primary	05000223504083	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K242146	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Upper limit of temperature: -
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight: -