OSSEOUS Gelatin Sponge Gyanec
- Primary DI
- 08904428748143
- Brand
- OSSEOUS Gelatin Sponge Gyanec
- Company
- EON MEDITECH PRIVATE LIMITED
- Model
- E91078025
- 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
| Code | Name |
|---|---|
| LAY | Methotrexate Control Materials |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| LAY | Methotrexate Control Materials | Clinical Toxicology | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 08904428748143 | Package | GS1 | 10 | In Commercial Distribution |
| 08906039313178 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 08904428748143 | 08904428748143 | 8904428748143 |
| 08906039313178 | 08906039313178 | 8906039313178 |
GMDN Terms
| Term | Definition |
|---|---|
| Gelatin haemostatic agent | A 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 |
|---|---|---|
| Height | 7 | Millimeter |
| Length | 80 | Millimeter |
| Width | 25 | Millimeter |
Storage And Handling
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 5 Degrees Celsius | 30 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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|---|---|---|---|---|
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| 08904428745326 | OSSEOUS- Skin Closure Tape | EA91066 | 2026-03-13 | |
| 08904428745333 | OSSEOUS- Skin Preparation Pad | EA91062 | 2026-03-13 | |
| 08904428798421 | OSSEOUS- ShowerProtect | EA91051 | 2026-03-13 | |
| 08904428798438 | OSSEOUS- NeckFit Tube Holder | EA91053 | 2026-03-13 | |
| 08904428798483 | OSSEOUS- Tube Cleaning Brush - 8mm | EA91071 | 2026-03-13 | |
| 08904428798469 | OSSEOUS-Cleaning Pad | EA91061 | 2026-03-13 | |
| 08904428799749 | OSSEOUS- Adhesion Remover Pad | EA91063 | 2026-03-13 | |
| 08904428798292 | OSSEOUS- TouchFree HME Series - Standard | EA910011 | 2026-03-13 | |
| 08906039318012 | OSSEOUS-Heat Moisture Exchanger-Air | EA91001 | 2026-03-13 | |
| 08904461030892 | OSSEOUS- Shaver Blade Tube | E2120-01 | 2026-03-13 | |
| 08904461031073 | OSSEOUS-Ear/Nasal Extractor | E3149 | 2026-03-13 | |
| 08904461055024 | OSSEOUS-SnorOFF | E31701 | 2026-03-13 | |
| 08904428798377 | OSSEOUS-Capsule | EA910018 | 2026-03-13 | |
| 08904428747672 | OSSEOUS Blade - Inferior turbinate - N Type | EI2222 | 2024-07-10 | |
| 08904428747665 | OSSEOUS Blade - Inferior turbinate - N Type | EI2221 | 2024-07-10 | |
| 08904428747658 | OSSEOUS Blade-Straight Sinus Blades - N Type | EI2220 | 2024-07-10 | |
| 08904428747641 | OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - N Type | EI2219 | 2024-07-10 | |
| 08904428747634 | OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - N Type | EI2218 | 2024-07-10 | |
| 08904428747627 | OSSEOUS Blade-Curved Sinus Blades - Type | EI2217 | 2024-07-10 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 08904428748136 | OSSEOUS Gelatin Sponge Nasal | EON MEDITECH PRIVATE LIMITED | LAY | 2024-07-08 |
| 08904428748327 | OSSEOUS GEL FOAM Sheet | EON MEDITECH PRIVATE LIMITED | LAY | 2024-07-04 |
| 08904428748310 | OSSEOUS Gelatin Sponge Dental Tampon | EON MEDITECH PRIVATE LIMITED | LAY | 2024-07-04 |
| 08904428748303 | OSSEOUS Gelatin Powder | EON MEDITECH PRIVATE LIMITED | LAY | 2024-07-04 |
| 08904428748082 | OSSEOUS Gelatin Sponge | EON MEDITECH PRIVATE LIMITED | LAY | 2024-07-04 |
| 08904428748099 | OSSEOUS Gelatin Sponge | EON MEDITECH PRIVATE LIMITED | LAY | 2024-07-04 |
| 08904428748105 | OSSEOUS Gelatin Sponge Bilatreral | EON MEDITECH PRIVATE LIMITED | LAY | 2024-07-04 |
| 08904428748112 | OSSEOUS Gelatin Sponge Unilateral | EON MEDITECH PRIVATE LIMITED | LAY | 2024-07-04 |
| 08904428748129 | OSSEOUS Gelatin Sponge | EON MEDITECH PRIVATE LIMITED | LAY | 2024-07-04 |
| 08904428748150 | OSSEOUS Gelatin Sponge | EON MEDITECH PRIVATE LIMITED | LAY | 2024-07-04 |
| 08904428748167 | OSSEOUS Gelatin Sponge | EON MEDITECH PRIVATE LIMITED | LAY | 2024-07-04 |
| 08904428748174 | OSSEOUS Gelatin Sponge | EON MEDITECH PRIVATE LIMITED | LAY | 2024-07-04 |
| 08904428748181 | OSSEOUS Gelatin Sponge Sterifen | EON MEDITECH PRIVATE LIMITED | LAY | 2024-07-04 |
| 08904428748198 | OSSEOUS Gelatin Sponge Strip | EON MEDITECH PRIVATE LIMITED | LAY | 2024-07-04 |
| 08904428748204 | OSSEOUS Gelatin Sponge Dental | EON MEDITECH PRIVATE LIMITED | LAY | 2024-07-04 |
| 08904428748211 | OSSEOUS Gelatin Sponge Dial | EON MEDITECH PRIVATE LIMITED | LAY | 2024-07-04 |
| 08904428748228 | OSSEOUS Gelatin Sponge | EON MEDITECH PRIVATE LIMITED | LAY | 2024-07-04 |
| 08904428748235 | OSSEOUS Gelatin Sponge | EON MEDITECH PRIVATE LIMITED | LAY | 2024-07-04 |
| 08904428748242 | OSSEOUS Gelatin Sponge | EON MEDITECH PRIVATE LIMITED | LAY | 2024-07-04 |
| 08904428748259 | OSSEOUS Gelatin Sponge Film | EON MEDITECH PRIVATE LIMITED | LAY | 2024-07-04 |
| 08904428748266 | OSSEOUS Gelatin Sponge MicroSponge | EON MEDITECH PRIVATE LIMITED | LAY | 2024-07-04 |
| 08904428748273 | OSSEOUS Gelatin Sponge MicroSponge | EON MEDITECH PRIVATE LIMITED | LAY | 2024-07-04 |
| 08904428748280 | OSSEOUS Gelatin Sponge Nasal Tampon | EON MEDITECH PRIVATE LIMITED | LAY | 2024-07-04 |
| 08904428748297 | OSSEOUS Gelatin Sponge Anal Tampon | EON MEDITECH PRIVATE LIMITED | LAY | 2024-07-04 |