Link OptiStems
- Primary DI
- 04026575284610
- Brand
- Link OptiStems
- Company
- WALDEMAR LINK GmbH & Co. KG
- Model
- 17-5011/01
- Catalog number
- 17-5011/01
- Device description
- Instrument tray - Link OptiStems
- Published
- 2024-07-30
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| FSM | Tray, Surgical, Instrument |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 04026575284610 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 04026575284610 | 04026575284610 | 4026575284610 |
GMDN Terms
| Term | Definition |
|---|
| Instrument tray, reusable | A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 315675488
- 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
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
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|---|
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| 04026575092239 | General Instrument | 151-07/07 | | 2026-02-02 |
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| 04026575129928 | MP Reconstruction System Instruments | 134-081/00 | | 2026-02-02 |
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| 04026575182022 | MP Monoblock Hip Stem Instruments | 136-011/00 | | 2026-02-02 |
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