OSSEOUS Gelatin Sponge Bilatreral

Primary DI
08904428748105
Brand
OSSEOUS Gelatin Sponge Bilatreral
Company
EON MEDITECH PRIVATE LIMITED
Model
E91048050
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

Related Records

Product Codes

CodeName
LAYMethotrexate Control Materials

Product Code Classifications

CodeDeviceSpecialtyClass
LAYMethotrexate Control MaterialsClinical Toxicology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08904428748105PackageGS110In Commercial Distribution
08906039313130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08904428748105089044287481058904428748105
08906039313130089060393131308906039313130

GMDN Terms

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

TypeValueUnit
Height4Millimeter
Length80Millimeter
Width50Millimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods

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

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