FDA UDI
In Commercial Distribution
🇺🇸 United States
27GA Curved Illuminating Laser Probe - Iridex
DI: 00632307002342
·
Model: 7627.IRI-00
·
Peregrine Surgical, Llc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- 27GA Curved Illuminating Laser Probe - Iridex
- Primary DI
- 00632307002342
- Version / Model
- 7627.IRI-00
- Company Name
- Peregrine Surgical, Llc
- Labeler DUNS
- 622467348
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-24
- Public Version
- 1
- Public Version Date
- 2024-10-02
- Public Version Status
- New
- Public Device Record Key
- 2d432fec-4571-4f6e-b375-159700b2ee08
Device Description
27GA Curved Illuminating Laser Probe - Iridex
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HQB | PHOTOCOAGULATOR AND ACCESSORIES | Ophthalmic | 886.4690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61162 | Ophthalmic laser system beam guide | A sterile, hand-held, probe-like device intended to be used in conjunction with an ophthalmic laser system during ophthalmic surgery to invasively direct and deliver laser energy to treat non-refractive conditions (e.g., to repair a retinal tear). It consists of a fibreoptic cable, a handpiece, and a distal invasive cannula/probe which may be available in a variety of configurations (e.g., bent or straight); it may be capable of further functionality (e.g., aspiration, illumination). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10632307002349 | GS1 | Box | 6 | In Commercial Distribution | |
| Primary | 00632307002342 | GS1 |
Customer Contacts
- Phone
- +1(215)348-0456
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K132614 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 27 Gauge Needle | ||
| Needle Gauge | 27 | Gauge |