OraFOAM™

Basic Information

• Brand Name: OraFOAM™
• Primary DI: 10381780508656
• Version / Model: ORAFOAM-PKG-18
• Catalog Number: ORAFOAM-PKG-18
• Company Name: Integra Lifesciences Corporation
• Labeler DUNS: 083171244
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 18
• Record Status: Published
• Publish Date: 2019-02-04
• Public Version: 6
• Public Version Date: 2023-12-19
• Public Version Status: Update
• Public Device Record Key: ffa76314-2151-4a89-8c27-bf23a181b7cc
• Distribution End Date: 2022-10-24

Device Description

OraFOAM™ Absorbable Collagen Hemostatic Sponge Contents: 1 sponge 1/2 in x 1 in (1.27 cm x 2.54 cm)

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: Yes
• 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
LMF	Agent, absorbable hemostatic, collagen based	General, Plastic Surgery	878.4490	3

GMDN Terms

Code	Name	Definition	Implantable	Status
47201	Collagen haemostatic agent, non-antimicrobial	A bioabsorbable device derived from animal collagen (e.g., bovine or porcine collagen) designed to produce a rapid haemostasis through platelet activation/aggregation (which initiates the haemostatic cascade leading to a fibrin clot) during a surgical procedure. It is applied directly to the wound where it remains to be absorbed by the body; it is not dedicated to a specific anatomy/application and does not contain an antimicrobial agent. It may be supplied as a fibrillar or soft, pliable pad/sponge or loose fibres; it may be applied in combination with fibrin adhesives. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780508656	GS1
Unit of Use	00381780508659	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P850010	007

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			1/2" x 1"

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Avoid excessive heat and humidity