AESCULAP
- Primary DI
- 04038653179206
- Brand
- AESCULAP
- Company
- Aesculap AG
- Model
- OM119R
- Catalog number
- OM119R
- Device description
- DAVIS-BOYLE Tongue Depressor, frame, for adolescents, non-sterile, reusable
- Published
- 2020-04-22
- 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 |
|---|
| FMA | DEPRESSOR, TONGUE, NON-SURGICAL |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| FMA | Depressor, Tongue, Non-Surgical | General Hospital | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 04038653179206 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 04038653179206 | 04038653179206 | 4038653179206 |
GMDN Terms
| Term | Definition |
|---|
| Tongue depressor, surgical | A hand-held surgical instrument designed to displace and maintain the tongue in a fixed position, usually by depressing it towards the floor of the mouth. It is typically a metallic (e.g., high-grade stainless steel) device either with a straight shape, or more frequently smoothly bent at its center (e.g., to a 90? arch). The proximal end is used as a handle, while the distal end (usually serrated and may include holes) is used to depress the tongue. The device is used in oral surgery (e.g., during tonsillectomy). This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 315018218
- 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
- false
- 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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| 00192029049396 | Tongue-Away Sheild | TP ORTHODONTICS INC | FMA | 2022-05-09 |
| 00192029049402 | Tongue-Away Sheild | TP ORTHODONTICS INC | FMA | 2022-05-09 |
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| 00192029049426 | Tongue-Away Sheild | TP ORTHODONTICS INC | FMA | 2022-05-09 |
| 00192029049433 | Tongue-Away Sheild | TP ORTHODONTICS INC | FMA | 2022-05-09 |
| 00192029049440 | Tongue-Away Sheild | TP ORTHODONTICS INC | FMA | 2022-05-09 |
| 00192029049457 | Tongue-Away Sheild | TP ORTHODONTICS INC | FMA | 2022-05-09 |
| 00192029049471 | Tongue-Away Sheild | TP ORTHODONTICS INC | FMA | 2022-05-09 |
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