FDA UDI
In Commercial Distribution
🇺🇸 United States
INTRECTOR®
DI: 00856222004193
·
Model: 71101
·
INSIGHT INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- INTRECTOR®
- Primary DI
- 00856222004193
- Version / Model
- 71101
- Catalog Number
- 71101
- 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
- b24895c9-129a-4255-b6a3-e8c48726bca8
Device Description
INTRECTOR® Handpiece for use with the INTRECTOR® Portable Vitrectomy System REF: 71200
Device Characteristics
- Single Use
- No
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- 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 |
|---|---|---|---|---|
| 34125 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00856222004193 | GS1 |
Customer Contacts
- Phone
- (772) 219-9393
- [email protected]