Rumex
- Primary DI
- 00840159909133
- Brand
- Rumex
- Company
- RUMEX INTERNATIONAL CORP.
- Model
- 10-030S
- Catalog number
- 10-030S
- Device description
- Schepens Orbital Retractor, Length 148 mm, Stainless Steel
- Published
- 2020-06-04
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
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 |
|---|---|---|---|---|
| 00840159909133 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00840159909133 | 00840159909133 | 840159909133 | 0840159909133 |
GMDN Terms
| Term | Definition |
|---|---|
| Intraocular retractor, reusable | A 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 small hook-like device which may include a retention bead or a self-retaining ring/frame, and is designed to be manipulated using another ophthalmic instrument; it is not a hand-held ophthalmic hook. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Dry Heat Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 041546137
- 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
- true
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00840159901397 | Rumex | 4-072T | 4-072T | 2020-07-27 |
| 00840159901403 | Rumex | 4-0741S | 4-0741S | 2020-07-27 |
| 00840159901410 | Rumex | 4-0741T | 4-0741T | 2020-07-27 |
| 00840159901427 | Rumex | 4-090T | 4-090T | 2020-07-27 |
| 00840159901434 | Rumex | 4-091S | 4-091S | 2020-07-27 |
| 00840159901441 | Rumex | 4-092T | 4-092T | 2020-07-27 |
| 00840159901458 | Rumex | 4-111T | 4-111T | 2020-07-27 |
| 00840159901465 | Rumex | 4-113T | 4-113T | 2020-07-27 |
| 00840159901472 | Rumex | 4-121S | 4-121S | 2020-07-27 |
| 00840159901489 | Rumex | 4-122S | 4-122S | 2020-07-27 |
| 00840159901496 | Rumex | 4-123S | 4-123S | 2020-07-27 |
| 00840159901502 | Rumex | 4-136S | 4-136S | 2020-07-27 |
| 00840159901519 | Rumex | 4-140T | 4-140T | 2020-07-27 |
| 00840159901526 | Rumex | 4-171S | 4-171S | 2020-07-27 |
| 00840159901533 | Rumex | 4-175T | 4-175T | 2020-07-27 |
| 00840159901540 | Rumex | 4-176T | 4-176T | 2020-07-27 |
| 00840159901557 | Rumex | 4-177S | 4-177S | 2020-07-27 |
| 00840159901564 | Rumex | 4-185S | 4-185S | 2020-07-27 |
| 00840159901571 | Rumex | 4-185T | 4-185T | 2020-07-27 |
| 00840159901588 | Rumex | 4-1906T | 4-1906T | 2020-07-27 |
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