Duns Number:305175344
Device Description: The kit is a convenient kit that includes SURGIFOAM® Absorbable Gelatin Powder, ref. 1978, The kit is a convenient kit that includes SURGIFOAM® Absorbable Gelatin Powder, ref. 1978, with a syringe and an applicator tip.
Catalog Number
-
Brand Name
SURGIFOAM® Absorbable Gelatin Powder Kit
Version/Model Number
1979
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004,P990004
Product Code
LMF
Product Code Name
Agent, Absorbable Hemostatic, Collagen Based
Public Device Record Key
101e7e3d-9847-4724-a23b-82c57327ccc1
Public Version Date
September 20, 2022
Public Version Number
12
DI Record Publish Date
September 24, 2014
Package DI Number
25712123000261
Quantity per Package
6
Contains DI Package
15712123000264
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box