23GA Soft Tip Aspirating Laser Probe – Iridex
Catalogue number PD723.62, listed by Peregrine Surgical, LLC., United States, under Instrument, Vitreous Aspiration And Cutting, Ac-Powered. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
3510(k) clearances naming this product code
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| ABA Medical Technology Co Ltd | Guang Dong | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Peregrine Surgical, LLC., United States |
|---|---|
| FDA product code | HQE |
| Device type | Instrument, Vitreous Aspiration And Cutting, Ac-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 886.4150 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K061024 |
| Record published | 2016-05-06 |
| Record revised | 2024-09-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 5 |
| Sizes | Needle gauge 23 G |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PD723.62 | 23 Gauge Needle | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bausch + Lomb | Bausch & Lomb Incorporated | 108 |
| Unity | Alcon Laboratories, Inc. | 47 |
| Synergetics | Synergetics USA, Inc. | 44 |
| Bi-Blade® | Medical Instrument Development Laboratories, Inc. | 28 |
| Instrument, Vitreous Aspiration And Cutting, Ac-Powered | Medical Instrument Development Laboratories, Inc. | 21 |
| Alcon | Alcon Laboratories, Inc. | 14 |
| Constellation | Alcon Laboratories, Inc. | 9 |
| Stellaris | Bausch & Lomb Incorporated | 6 |
| EVA Nexus™ Posterior 25G TDC Pack | D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. | 4 |
| EVA Nexus™ Posterior 23G TDC Pack | D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. | 4 |
| EVA Nexus™ Posterior 27G TDC Pack | D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. | 4 |
| Engauge, Vektor | Alcon Laboratories, Inc. | 3 |
Showing 12 of 65. All products under Instrument, Vitreous Aspiration And Cutting, Ac-Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K980400 | 1998-04-30 |
| K980399 | 1998-04-30 |
| K940391 | 1994-06-08 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.