Duns Number:828348391
Device Description: 1 INTRECTOR® Probe Kit containing 1 Each Syringe 1ml, 1 Each Syringe 3ml, & 1 Each Disposa 1 INTRECTOR® Probe Kit containing 1 Each Syringe 1ml, 1 Each Syringe 3ml, & 1 Each Disposable 23 Ga Vitrectomy Probe
Catalog Number
71004
Brand Name
INTRECTOR®
Version/Model Number
71004
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
-
Product Code Name
-
Public Device Record Key
29218976-7f55-4fd5-b76e-8e0101ce61df
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 2016
Package DI Number
10856222004633
Quantity per Package
5
Contains DI Package
00856222004636
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |