Primary Device ID | 10856222004633 |
NIH Device Record Key | 29218976-7f55-4fd5-b76e-8e0101ce61df |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | INTRECTOR® |
Version Model Number | 71004 |
Catalog Number | 71004 |
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 | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | (772) 219-9393 |
CustomerService@InsightInstruments.com |
Needle Gauge | 23 Gauge |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00856222004636 [Primary] |
GS1 | 10856222004633 [Package] Contains: 00856222004636 Package: Case [5 Units] In Commercial Distribution |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-09-23 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
INTRECTOR 78854959 3494022 Dead/Cancelled |
Insight Instruments, Inc. 2006-04-05 |