AMO TAC VITRECTOMY HANDPIECE
- Primary DI
- 05050474520479
- Brand
- AMO TAC VITRECTOMY HANDPIECE
- Company
- JOHNSON & JOHNSON SURGICAL VISION, INC.
- Model
- OM0201011D
- Catalog number
- OM0201011D
- Device description
- PARTS LIST, TAC VITRECTOMY HANDPIECE
- Published
- 2016-09-02
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- false
Product Codes
| Code | Name |
|---|
| HKP | INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, BATTERY-POWERED |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| HKP | Instrument, Vitreous Aspiration And Cutting, Battery-Powered | Ophthalmic | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 05050474520479 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 05050474520479 | 05050474520479 | 5050474520479 |
GMDN Terms
| Term | Definition |
|---|
| Vitrectomy system handpiece | A holder for a detachable, micro-cutting tip that converts the energy (e.g., ultrasonic, piezoelectric) produced by a system generator into a mechanical oscillating-cutting action to remove (nibble away) vitreous humour (the jelly-like substance that fills the centre of the eye) during ophthalmic surgery. This device will typically be activated by the surgeon using a foot control and provide or support the irrigation/suction systems needed to supply replacement fluid and remove debris. The handpiece is typically designed in the form of a pen or pencil, and connected to the generator via a cable. This is a reusable device intended to be sterilized prior to use. |
Regulatory Flags
- DUNS number
- 103021940
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 00812480010307 | NA | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. | HKP | 2017-06-24 |
| 00812480010314 | NA | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. | HKP | 2017-06-24 |
| 00852475007004 | Insight Instruments, Inc. Vitreous Biopsy Probe 27 Ga | INSIGHT INSTRUMENTS, INC. | HKP | 2016-09-23 |
| 00852475007011 | Insight Instruments, Inc. Vitreous Biopsy Probe 27 Ga | INSIGHT INSTRUMENTS, INC. | HKP | 2016-09-23 |
| 00856222004186 | INTRECTOR® | INSIGHT INSTRUMENTS, INC. | HKP | 2016-09-23 |
| 00856222004193 | INTRECTOR® | INSIGHT INSTRUMENTS, INC. | HKP | 2016-09-23 |
| 00856222004643 | INTRECTOR® | INSIGHT INSTRUMENTS, INC. | HKP | 2016-09-23 |
| 00856222004667 | RETRECTOR® | INSIGHT INSTRUMENTS, INC. | HKP | 2016-09-23 |
| 00812480010215 | NA | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. | HKP | 2016-09-23 |
| 00812480010222 | NA | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. | HKP | 2016-09-23 |
| 00812480010277 | NA | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. | HKP | 2016-09-23 |
| 00812480010949 | NA | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. | HKP | 2016-09-23 |
| 00812480010956 | NA | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. | HKP | 2016-09-23 |
| 00812480010963 | NA | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. | HKP | 2016-09-23 |
| 05050474520493 | AMO LIMBAL NEEDLE ASSEMBLY | JOHNSON & JOHNSON SURGICAL VISION, INC. | HKP | 2016-09-02 |
| 05050474520509 | AMO TAC INFUSION SLEEVE | JOHNSON & JOHNSON SURGICAL VISION, INC. | HKP | 2016-09-02 |
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