GELITA MEDICAL GMBH

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3010208179	3010208179	GELITA MEDICAL GMBH	1	N	2020-04-25	Uferstrabe 7 Eberbach Baden-Wurttemberg DE 69412

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
150660	1340778036	K060878	GELITA-SPON ABSORBABLE GELATIN SPONGE, USP	KHJ	2006-04-13

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
KHJ	1	2006-04-13

GUDID#

GELITA-SPON® STANDARD - 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.
GELITA MEDICAL GmbH
2021-03-21
GELITA-SPON® STANDARD - 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.
GELITA MEDICAL GmbH
2021-07-28
GELITA-SPON® STANDARD - 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.
GELITA MEDICAL GmbH
2021-07-27
GELITA-SPON® STANDARD - 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.
GELITA MEDICAL GmbH
2021-07-27
GELITA-SPON® STANDARD - 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.
GELITA MEDICAL GmbH
2021-07-27
GELITA-SPON® STANDARD - 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.
GELITA MEDICAL GmbH
2021-07-27
GELITA-SPON® STANDARD - 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.
GELITA MEDICAL GmbH
2021-07-27
GELITA-SPON® STANDARD - The GELITA-SPON® Absorbable Gelatin Sponge, U.S.P. (“Gelita-Spon”) is made of 100% purified porcine gelatine and is of neutral character in nature. GELITA-SPON® Absorbable Gelatin Sponge is non-pyrogenic. It is intended for use to control minimal bleeding by tamponade 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 absorptive capacity 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.
GELITA MEDICAL GmbH
2021-07-27
GELITA-SPON® STANDARD - The GELITA-SPON® Absorbable Gelatin Sponge, U.S.P. (“Gelita-Spon”) is made of 100% purified porcine gelatine and is of neutral character in nature. GELITA-SPON® Absorbable Gelatin Sponge is non-pyrogenic. It is intended for use to control minimal bleeding by tamponade 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 absorptive capacity 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.
GELITA MEDICAL GmbH
2021-07-27
GELITA-SPON® STANDARD - The GELITA-SPON® Absorbable Gelatin Sponge, U.S.P. (“Gelita-Spon”) is made of 100% purified porcine gelatine and is of neutral character in nature. GELITA-SPON® Absorbable Gelatin Sponge is non-pyrogenic. It is intended for use to control minimal bleeding by tamponade 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 absorptive capacity 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.
GELITA MEDICAL GmbH
2021-07-27
GELITA-SPON® STANDARD - The GELITA-SPON® Absorbable Gelatin Sponge, U.S.P. (“Gelita-Spon”) is made of 100% purified porcine gelatine and is of neutral character in nature. GELITA-SPON® Absorbable Gelatin Sponge is non-pyrogenic. It is intended for use to control minimal bleeding by tamponade 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 absorptive capacity 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.
GELITA MEDICAL GmbH
2021-07-28
GELITA-SPON® STANDARD - The GELITA-SPON® Absorbable Gelatin Sponge, U.S.P. (“Gelita-Spon”) is made of 100% purified porcine gelatine and is of neutral character in nature. GELITA-SPON® Absorbable Gelatin Sponge is non-pyrogenic. It is intended for use to control minimal bleeding by tamponade 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 absorptive capacity 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.
GELITA MEDICAL GmbH
2021-07-27
GELITA-SPON® STANDARD - The GELITA-SPON® Absorbable Gelatin Sponge, U.S.P. (“Gelita-Spon”) is made of 100% purified porcine gelatine and is of neutral character in nature. GELITA-SPON® Absorbable Gelatin Sponge is non-pyrogenic. It is intended for use to control minimal bleeding by tamponade 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 absorptive capacity 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.
GELITA MEDICAL GmbH
2021-03-21