FDA UDI
In Commercial Distribution
🇺🇸 United States
RETRECTOR®
DI: 00856222004667
·
Model: 71005.100
·
INSIGHT INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- RETRECTOR®
- Primary DI
- 00856222004667
- Version / Model
- 71005.100
- Company Name
- INSIGHT INSTRUMENTS, INC.
- Labeler DUNS
- 828348391
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 4422a790-b4ea-4d7a-ae08-0605b5c4f3a8
Device Description
1 Each Disposable 23 Ga vitrectomy probe with retractable tip for use with the INTRECTOR® Kit during vitreo-retinal surgery
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HKP | Instrument, Vitreous Aspiration And Cutting, Battery-Powered | Ophthalmic | 886.4150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47424 | Vitrectomy system handpiece tip | A sterile, micro-cutting device that is attached to a vitrectomy system handpiece for insertion into the eye, in order to remove (nibble away) the vitreous humour (the jelly-like substance that fills the centre of the eye) during ophthalmic surgery. The handpiece converts an energy (e.g., ultrasonic, piezoelectric) produced by a system generator into a mechanical oscillating-cutting action applied by this knife-like device. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00856222004667 | GS1 |
Customer Contacts
- Phone
- (772) 219-9393
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 23 | Gauge |