SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. Oral Sponge

Basic Information

• Brand Name: SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. Oral Sponge
• Primary DI: 15712123000141
• Version / Model: 1969
• Company Name: Ferrosan Medical Devices A/S
• Labeler DUNS: 305175344
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-20
• Public Version: 12
• Public Version Date: 2023-08-14
• Public Version Status: Update
• Public Device Record Key: b1247f66-aac5-4431-9584-54e2ead0ec0c

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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
LMF	Agent, Absorbable Hemostatic, Collagen Based	General, Plastic Surgery	878.4490	3

GMDN Terms

Code	Name	Definition	Implantable	Status
48170	Gelatin haemostatic agent	A sterile, bioabsorbable device derived from animal gelatin (typically pork skin gelatin) that is intended to be applied to surgical and traumatic wounds to facilitate local haemostasis through its high blood-absorbing capacity; it does not contain an antimicrobial agent. It is typically in the form of a pad/sponge and has no intrinsic haemostatic action but induces haemostasis through its intensely porous structure which enables it to absorb many times its weight in blood; the device is intended to remain in the wound to be absorbed by the body. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15712123000141	GS1
Package	25712123000148	GS1		24	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
P990004	010
P990004	013
P990004	026
P990004	029
P990004	036
P990004	039
P990004	041
P990004	047
P990004	049
P990004	051
P990004	052
P990004	054
P990004	060

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			1cm x 1cm x 1cm

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 59 – 86 Degrees Fahrenheit