Gelfoam

Basic Information

• Brand Name: Gelfoam
• Primary DI: 10300090433045
• Version / Model: 1 g Powder
• Company Name: PHARMACIA & UPJOHN COMPANY LLC
• Labeler DUNS: 618054084
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-01
• Public Version: 6
• Public Version Date: 2020-12-17
• Public Version Status: Update
• Public Device Record Key: ff9a68c9-ad89-445b-800f-84ffe4411cab

Device Description

Absorbable Hemostatic Powder, Collagen Based

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: Yes
• 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
Package	00300090433048	GS1	Carton	6	In Commercial Distribution
Primary	10300090433045	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
N18286	017
N18286	018
N18286	020
N18286	021
N18286	023
N18286	024
N18286	025
N18286	026

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Approximately 1.2 g actual fill weight
Weight	1	Gram

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: See USP Controlled Room Temperature
• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius