Duns Number:330774063
Device Description: The GELITA-SPON® Absorbable Gelatin Sponge, U.S.P. (“Gelita-Spon”) is made of 100% purifie The GELITA-SPON® Absorbable Gelatin Sponge, U.S.P. (“Gelita-Spon”) is made of 100% purified porcine gelatine and is of neutralcharacter in nature. GELITA-SPON® Absorbable Gelatin Sponge is non-pyrogenic. It is intended for use to control minimal bleeding bytamponade effect, blood absorption and platelet aggregation following ENT surgery. It is insoluble in water and fully absorbable.Its porous structure and interstices enables the product to absorb more than 35 times its own weight of blood and fluids. The absorptivecapacity of GELITA-SPON® is a function of its physical size, increasing as the amount of gelatine increases. It is supplied in several sizes.It is packaged individually in (double) blister, pouch or jar/container packaging, sterilized by gamma rays, and is for single use only.
Catalog Number
-
Brand Name
GELITA-SPON® STANDARD
Version/Model Number
GS-060
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K060878,K060878,K060878
Product Code
KHJ
Product Code Name
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Public Device Record Key
13783385-9924-4c4d-a9c9-cd1e86b6fcf4
Public Version Date
August 04, 2021
Public Version Number
1
DI Record Publish Date
July 27, 2021
Package DI Number
04260293130082
Quantity per Package
10
Contains DI Package
04260293133083
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Suture Box