Novo Surgical
- Primary DI
- 00842331190643
- Brand
- Novo Surgical
- Company
- NOVO SURGICAL, INC.
- Model
- E7215-19
- Catalog number
- E7215-19
- Device description
- shambaugh-derlacki needle, straight tip w/ angled shaft, 6-1/4" (16.0 cm), fine
- Published
- 2023-12-18
- 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 |
|---|
| GDL | NEEDLE, SUTURING, REUSABLE |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| GDL | Needle, Suturing, Reusable | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00842331190643 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00842331190643 | 00842331190643 | 842331190643 | 0842331190643 |
GMDN Terms
| Term | Definition |
|---|
| Middle ear pick | A fine, hand-held manual surgical instrument intended to be used to manipulate the structures of the middle ear (e.g., the stapes). It is typically comprised of a proximal handle that tapers to a shaft which terminates in a fine distal tip bent at 90 degrees to the shaft. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 033029433
- 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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