AccessGUDID - DEVICE: SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. (15712123000189)

GUDID

Device Identifier (DI) Information

Brand Name: SURGIFOAM® Absorbable Gelatin Sponge, U.S.P.
Version or Model: 1974
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Ferrosan Medical Devices A/S

Primary DI Number: 15712123000189
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305175344 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LMF	Agent, Absorbable Hemostatic, Collagen Based

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P990004	002
P990004	006
P990004	013
P990004	026
P990004	027
P990004	036
P990004	041
P990004	049
P990004	050
P990004	052
P990004	054
P990004	056
P990004	069
P990004	070
P990004	071

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Area/Surface Area: 100 Square centimeter
Device Size Text, specify: 8cm x 12.5cm x 1cm

Device Record Status

Public Device Record Key: 1da0c298-8e5b-4330-ab0b-1795a9138888
Public Version Date: March 12, 2025
Public Version Number: 12
DI Record Publish Date: September 20, 2014