Visitec®
- Primary DI
- 00886158102496
- Brand
- Visitec®
- Company
- Beaver-Visitec International, Inc.
- Model
- 585254
- Catalog number
- 585254
- Device description
- LASIK Cap / Flap Elevator [Kritzinger-Updegraff]
- Published
- 2021-12-21
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| MDM | Instrument, Manual, Surgical, General Use |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 30886158102497 | Primary | GS1 | 0 | |
| 00886158102496 | Unit of Use | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 30886158102497 | 30886158102497 | | |
| 00886158102496 | 00886158102496 | 886158102496 | 0886158102496 |
GMDN Terms
| Term | Definition |
|---|
| Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use | A rigid or semi-rigid tube (non-illuminating) designed to be inserted into the eye to facilitate infusion, irrigation, and/or aspiration of fluids/gases during ophthalmic surgery (e.g., phacoemulsification, vitreoretinal surgery, sub-Tenon’s anaesthesia, capsule polishing). It is a single- or multi-lumen device, typically made of high-grade stainless steel, and may include a length of flexible tubing or a basic handle (without controls). It may be blunt, or include a sharp angled tip/hook (e.g., irrigating cystotome for capsulotomy), however it does not have a sharp bevelled end for initial puncture of the eye (i.e., not a needle). This is a single-use device. |
Contacts
| Phone | Email |
|---|
| 18669068080 | customersupport@beaver-visitec.com |
Regulatory Flags
- DUNS number
- 001406024
- Device count
- 5
- 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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