OSSEOUS GEL FOAM Sheet

Primary DI
08904428748327
Brand
OSSEOUS GEL FOAM Sheet
Company
EON MEDITECH PRIVATE LIMITED
Model
E9115200
Device description
"Absorbable Haemostatic Gelatin Sponge is a sterile malleable, water-insoluble, Gelatin absorbable sponge intended for haemostatic use by applying to a bleeding surface. Absorbable Haemostatic Gelatin Sponge is non-pyrogenic and biocompatible. Absorbable Haemostatic Gelatin Sponge is a surgical haemostatic sponge, manufactured from highly purified first grade gelatin material for use in various surgical procedures. When implanted in vivo and used in appropriate amounts, it is completely absorbed within 3-4 weeks. When applied to bleeding mucosal regions, it liquefies within 2 to 5 days. Absorbable Haemostatic Gelatin Sponge have a porous structure which activates the thrombocytes at the moment blood comes in contact with the matrix of the sponge. This causes the thrombocytes to release a series of substances which promote their aggregation at the same time as their surfaces change character, thus enabling them to act as a catalyst for the formation of the fibrin. "
Published
2024-07-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LAYMethotrexate Control Materials

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LAYMethotrexate Control MaterialsClinical Toxicology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08904428748327PackageGS12In Commercial Distribution
08904428723898PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08904428748327089044287483278904428748327
08904428723898089044287238988904428723898

GMDN Terms#

Term, Definition table
TermDefinition
Gelatin haemostatic agentA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height15Millimeter
Length200Millimeter
Width150Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
930270428
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08904428721399OSSEOUS- Skin Closure TapeEA910662026-03-13
08904428721405OSSEOUS- Skin Preparation PadEA910622026-03-13
08904428744916OSSEOUS- ShowerProtectEA910512026-03-13
08904428744947OSSEOUS- NeckFit Tube HolderEA910532026-03-13
08904428744954OSSEOUS- Tube Cleaning Brush - 8mmEA910712026-03-13
08904428744992OSSEOUS-Cleaning PadEA910612026-03-13
08904428745012OSSEOUS- Adhesion Remover PadEA910632026-03-13
08904428745067OSSEOUS- TouchFree HME Series - StandardEA9100112026-03-13
08904461000499OSSEOUS-Heat Moisture Exchanger-AirEA910012026-03-13
08904461028783OSSEOUS- Shaver Blade Tube E2120-012026-03-13
08904461031080OSSEOUS-Ear/Nasal ExtractorE31492026-03-13
08904461055031OSSEOUS-SnorOFFE317012026-03-13
08904461055697OSSEOUS-CapsuleEA9100182026-03-13
00890446104932OSSEOUS-Endoscrub 4 mm ( 0° )EI29012026-03-13
08904428745326OSSEOUS- Skin Closure TapeEA910662026-03-13
08904428745333OSSEOUS- Skin Preparation PadEA910622026-03-13
08904428798421OSSEOUS- ShowerProtectEA910512026-03-13
08904428798438OSSEOUS- NeckFit Tube HolderEA910532026-03-13
08904428798483OSSEOUS- Tube Cleaning Brush - 8mmEA910712026-03-13
08904428798469OSSEOUS-Cleaning PadEA910612026-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08906039313161OSSEOUS Gelatin Sponge Nasal EON MEDITECH PRIVATE LIMITEDLAY2024-07-08
08904428748136OSSEOUS Gelatin Sponge Nasal EON MEDITECH PRIVATE LIMITEDLAY2024-07-08
08904428723898OSSEOUS GEL FOAM Sheet EON MEDITECH PRIVATE LIMITEDLAY2024-07-04
08904428723904OSSEOUS Gelatin Sponge Dental Tampon EON MEDITECH PRIVATE LIMITEDLAY2024-07-04
08904428723911OSSEOUS Gelatin Powder EON MEDITECH PRIVATE LIMITEDLAY2024-07-04
08906039313116OSSEOUS Gelatin Sponge EON MEDITECH PRIVATE LIMITEDLAY2024-07-04
08906039313123OSSEOUS Gelatin Sponge EON MEDITECH PRIVATE LIMITEDLAY2024-07-04
08906039313130OSSEOUS Gelatin Sponge BilatreralEON MEDITECH PRIVATE LIMITEDLAY2024-07-04
08906039313147OSSEOUS Gelatin Sponge Unilateral EON MEDITECH PRIVATE LIMITEDLAY2024-07-04
08906039313154OSSEOUS Gelatin SpongeEON MEDITECH PRIVATE LIMITEDLAY2024-07-04
08906039313178OSSEOUS Gelatin Sponge Gyanec EON MEDITECH PRIVATE LIMITEDLAY2024-07-04
08906039313185OSSEOUS Gelatin Sponge EON MEDITECH PRIVATE LIMITEDLAY2024-07-04
08906039313192OSSEOUS Gelatin Sponge EON MEDITECH PRIVATE LIMITEDLAY2024-07-04
08906039313208OSSEOUS Gelatin Sponge EON MEDITECH PRIVATE LIMITEDLAY2024-07-04
08906039313215OSSEOUS Gelatin Sponge Sterifen EON MEDITECH PRIVATE LIMITEDLAY2024-07-04
08906039313222OSSEOUS Gelatin Sponge Strip EON MEDITECH PRIVATE LIMITEDLAY2024-07-04
08906039313239OSSEOUS Gelatin Sponge Dental EON MEDITECH PRIVATE LIMITEDLAY2024-07-04
08906039313246OSSEOUS Gelatin Sponge Dial EON MEDITECH PRIVATE LIMITEDLAY2024-07-04
08906039313253OSSEOUS Gelatin Sponge EON MEDITECH PRIVATE LIMITEDLAY2024-07-04
08906039313260OSSEOUS Gelatin Sponge EON MEDITECH PRIVATE LIMITEDLAY2024-07-04
08906039313277OSSEOUS Gelatin Sponge EON MEDITECH PRIVATE LIMITEDLAY2024-07-04
08906039313284OSSEOUS Gelatin Sponge Film EON MEDITECH PRIVATE LIMITEDLAY2024-07-04
08906039313291OSSEOUS Gelatin Sponge MicroSponge EON MEDITECH PRIVATE LIMITEDLAY2024-07-04
08906039313307OSSEOUS Gelatin Sponge MicroSponge EON MEDITECH PRIVATE LIMITEDLAY2024-07-04
08906039313314OSSEOUS Gelatin Sponge Nasal TamponEON MEDITECH PRIVATE LIMITEDLAY2024-07-04
08906039313321OSSEOUS Gelatin Sponge Anal Tampon EON MEDITECH PRIVATE LIMITEDLAY2024-07-04
08904428748310OSSEOUS Gelatin Sponge Dental Tampon EON MEDITECH PRIVATE LIMITEDLAY2024-07-04
08904428748303OSSEOUS Gelatin Powder EON MEDITECH PRIVATE LIMITEDLAY2024-07-04
08904428748082OSSEOUS Gelatin Sponge EON MEDITECH PRIVATE LIMITEDLAY2024-07-04
08904428748099OSSEOUS Gelatin Sponge EON MEDITECH PRIVATE LIMITEDLAY2024-07-04