ENDORET KIT
- Primary DI
- 08435389828075
- Brand
- ENDORET KIT
- Company
- BIOTECHNOLOGY INSTITUTE SL
- Model
- EDK1-SCP-US
- Published
- 2025-04-14
- 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 |
|---|
| ORG | Platelet And Plasma Separator For Bone Graft Handling |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| ORG | Platelet And Plasma Separator For Bone Graft Handling | Hematology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 08435389828075 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 08435389828075 | 08435389828075 | 8435389828075 |
GMDN Terms
| Term | Definition |
|---|
| Haematological concentrate system preparation kit, platelet concentration | A collection of devices designed to prepare platelet-rich plasma (PRP) or platelet-rich fibrin matrix (PRFM) from an autologous blood specimen for application to soft-tissue wounds and injured bone to accelerate healing and/or achieve haemostasis. It includes single- or double- (concentric) barrel syringe(s) with connecting tubes and caps. Blood is collected by venous puncture and processed in a centrifuge, increasing the concentration of platelets within the plasma or fibrin matrix; this may be done at the point-of-care. This is a single-use device. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 4 Degrees Celsius | 25 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 461665312
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 08435389828952 | EXTRACTOR FOR IMPLANTS 8 | EXIM8 | | 2026-01-30 |
| 08435389828969 | EXTRACTOR FOR IMPLANTS 9 | EXIM9 | | 2026-01-30 |
| 08435389829027 | SHORT DRILL; Ø2,2 MM | F22CS | | 2026-01-30 |
| 08435389829034 | SHORT DRILL; Ø2,3 MM | F23CS | | 2026-01-30 |
| 08435389829041 | SHORT DRILL; Ø2,4 MM | F24CS | | 2026-01-30 |
| 08435389829058 | SHORT DRILL; Ø2,0 MM | F20CS | | 2026-01-30 |
| 08435389829096 | FLATTENING FRONT CUTTING SHORT DRILL; Ø5.5 | FCFA55C | | 2026-01-30 |
| 08435389830061 | EXTRA SHORT INITIAL DRILL | FIXS | | 2026-01-30 |
| 08435389830078 | EXTRA SHORT DRILL; Ø1,8 MM | F18XS | | 2026-01-30 |
| 08435389830085 | EXTRA SHORT DRILL; Ø1,8/2,5 MM | F1825XS | | 2026-01-30 |
| 08435389830092 | EXTRA SHORT DRILL; Ø2,5 MM | F25XS | | 2026-01-30 |
| 08435389830108 | EXTRA SHORT DRILL; Ø2,8 MM | F28XS | | 2026-01-30 |
| 08435389830115 | EXTRA SHORT DRILL; Ø3 MM | F30XS | | 2026-01-30 |
| 08435389830269 | HEATING OVEN H-PLUS | BTI H-PLUS | | 2026-01-30 |
| 08435389830276 | DRILL HOLDER FOR EXTRA SHORT DRILLS | FFXS | | 2026-01-30 |
| 08435389830320 | SHORT DRILL; Ø1.5 MM | F15CS | | 2026-01-30 |
| 08435389829706 | EXPANDED SQUARE INTERFACE; MULTI-IM ABUTMENT; WIDE PLATFORM | ISMIPAX | | 2026-01-29 |
| 08435389829713 | EXPANDED SQUARE INTERFACE; UNIT ABUTMENT; WIDE PLATFORM | ISMIUPAX | | 2026-01-29 |
| 08435389829843 | MULTI-IM ABUTMENT; INTERNA 3.0 PLATFORM; Ø3,5; H 4,5MM | INTMIP33545 | | 2026-01-29 |
| 08435389829850 | MULTI-IM ABUTMENT; INTERNA 3.0 PLATFORM; H 4,5MM | INTMIP345 | | 2026-01-29 |
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