BREAST REDUCTION MARKER
- Primary DI
- 00192896098565
- Brand
- BREAST REDUCTION MARKER
- Company
- SONTEC INSTRUMENTS, INC.
- Model
- 475-916L
- Catalog number
- 475-916L
- Device description
- BREAST REDUCTION MARKER LARGE
- Published
- 2019-08-15
- Public version status
- Update
- 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 |
|---|
| GAF | Spatula, Surgical, General & Plastic Surgery |
| MDM | Instrument, Manual, Surgical, General Use |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| GAF | Spatula, Surgical, General & Plastic Surgery | General, Plastic Surgery | 1 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00192896098565 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00192896098565 | 00192896098565 | 192896098565 | 0192896098565 |
GMDN Terms
| Term | Definition |
|---|
| Skin marking guide, reusable | A device intended to be used as a guide to create an accurate mark on the skin surface with a drawing skin marker (e.g., a skin marking pen), or by itself after having been dipped in a marking agent (e.g., ink), typically to outline a surgical incision site or for dermatology applications. It is typically shaped specifically for its intended application. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization;Dry Heat Sterilization |
Regulatory Flags
- DUNS number
- 040729840
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- true
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