Instrument Tray
- Primary DI
- D77990110619
- Brand
- Instrument Tray
- Company
- COSMEDENT, INC.
- Model
- 901106
- Published
- 2020-02-10
- 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
Related Records
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 |
|---|---|---|---|---|
| D77990110619 | Primary | HIBCC | 0 |
GMDN Terms
| Term | Definition |
|---|---|
| Instrument tray | A container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. This is a reusable device. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 113911689
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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|---|---|---|---|---|
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| D7796722B11 | Bulkfill | 6722B1 | 2022-03-01 | |
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| D77920310412 | 22 Gauge Black Tips | 203104 | 2021-11-11 | |
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| D77920320615 | Connect 4:1 Tips | 203206 | 2021-11-11 | |
| D77920330211 | CosmeCore IntraOral Tips | 203302 | 2021-11-11 | |
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