Duns Number:828348391
Device Description: 1 RETRECTOR® Probe Kit containing 1 Each Syringe 10ml & 1 Each Disposable 23 Ga Vitrectomy 1 RETRECTOR® Probe Kit containing 1 Each Syringe 10ml & 1 Each Disposable 23 Ga Vitrectomy Probe with retractable tip
Catalog Number
71005
Brand Name
RETRECTOR®
Version/Model Number
71005
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
11f845a9-9f0d-4fe8-bd48-08f3866b10c5
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 2016
Package DI Number
10856222004671
Quantity per Package
5
Contains DI Package
00856222004674
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 |