FDA UDI
In Commercial Distribution
🇺🇸 United States
RETRECTOR®
DI: 00856222004674
·
Model: 71005
·
INSIGHT INSTRUMENTS, INC.
Product Codes
0
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- RETRECTOR®
- Primary DI
- 00856222004674
- Version / Model
- 71005
- Catalog Number
- 71005
- 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
- 11f845a9-9f0d-4fe8-bd48-08f3866b10c5
Device Description
1 RETRECTOR® Probe Kit containing 1 Each Syringe 10ml & 1 Each Disposable 23 Ga Vitrectomy Probe with retractable tip
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
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 |
|---|---|---|---|---|---|---|
| Package | 10856222004671 | GS1 | Case | 5 | In Commercial Distribution | |
| Primary | 00856222004674 | GS1 |
Customer Contacts
- Phone
- (772) 219-9393
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 23 | Gauge |