INTRECTOR® 71101
GUDID 00856222004193
INTRECTOR® Handpiece for use with the INTRECTOR® Portable Vitrectomy System REF: 71200
INSIGHT INSTRUMENTS, INC.
Vitrectomy system handpiece| Primary Device ID | 00856222004193 |
| NIH Device Record Key | b24895c9-129a-4255-b6a3-e8c48726bca8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INTRECTOR® |
| Version Model Number | 71101 |
| Catalog Number | 71101 |
| Company DUNS | 828348391 |
| Company Name | INSIGHT INSTRUMENTS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | (772) 219-9393 |
| CustomerService@InsightInstruments.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00856222004193 [Primary] |
FDA Product Code
| HKP | Instrument, Vitreous Aspiration And Cutting, Battery-Powered |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-23 |
On-Brand Devices [INTRECTOR®]
| 00856222004759 | INTRECTOR® Portable Vitrectomy System including REF: 71102 Power Unit & REF: 71101 Handpiece |
| 00856222004643 | 1 Disposable 23 Ga Vitrectomy Probe for use with the INTRECTOR® KIT |
| 10856222004633 | 1 INTRECTOR® Probe Kit containing 1 Each Syringe 1ml, 1 Each Syringe 3ml, & 1 Each Disposable 2 |
| 00856222004193 | INTRECTOR® Handpiece for use with the INTRECTOR® Portable Vitrectomy System REF: 71200 |
| 00856222004186 | INTRECTOR® Power Unit for use with the INTRECTOR® Portable Vitrectomy System REF: 71200 |
Trademark Results [INTRECTOR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INTRECTOR 78854959 3494022 Dead/Cancelled |
Insight Instruments, Inc. 2006-04-05 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.