Disposable Iris Retractor Hook
- Primary DI
- 00856312006991
- Brand
- Disposable Iris Retractor Hook
- Company
- KATALYST SURGICAL LLC
- Model
- D4176-2
- Device description
- Box of 2, Disposable Iris Retractor Hook
- Published
- 2016-08-08
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| HNI | Retractor, Ophthalmic |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| HNI | Retractor, Ophthalmic | Ophthalmic | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00856312006991 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00856312006991 | 00856312006991 | 856312006991 | 0856312006991 |
GMDN Terms
| Term | Definition |
|---|
| Intraocular retractor, single-use | A sterile, dedicated ophthalmic surgical instrument intended to be used explicitly for the temporary mechanical retraction/dilatation of intraocular tissues (e.g., iris) during ophthalmic surgery. It is typically a self-retaining ring/frame or a small hook-like device which may include a retention bead, and is usually designed to be manipulated using another ophthalmic instrument. This is a single-use device. |
Regulatory Flags
- DUNS number
- 007883297
- 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
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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