Biatain Silicone Ag Heel

Basic Information

• Brand Name: Biatain Silicone Ag Heel
• Primary DI: 05701780211420
• Version / Model: 39652
• Catalog Number: 39652
• Company Name: Coloplast A/S
• Labeler DUNS: 305524696
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-30
• Public Version: 1
• Public Version Date: 2022-12-08
• Public Version Status: New
• Public Device Record Key: 7a0ad648-0fa2-49de-a6ea-a176af29beb5

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Unsafe
• 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
FRO	Dressing, wound, drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
48124	Exudate-absorbent dressing, non-gel, antimicrobial	A wound covering intended to absorb exudates and blood from a wound (e.g., ulcers, burns, surgical wounds, lacerations, abrasions, and/or percutaneous device wounds), and that contains an antimicrobial agent [e.g., silver (Ag), chlorhexidine gluconate (CHG)]. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudate. It is intended to create a moist wound-healing environment and/or protect wounds from external contamination by microorganisms from the periwound skin. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, or powder. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05701780210416	GS1	Retail Box	5	In Commercial Distribution
Primary	05701780211420	GS1
Package	05701780210423	GS1	Shipper Box	8	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K191536	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Pad Length - cm 14
Width	7	Inch
Device Size Text, specify			Pad Length - in 5.5
Length	18	Centimeter
Device Size Text, specify			Pad Width - cm 13.5
Length	7	Inch
Width	18	Centimeter
Device Size Text, specify			Dressing Shape Heel
Device Size Text, specify			Pad Width - in 5.3

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do not use if package is damaged and consult IFU. Do not resterilize.