Duns Number:081277700
Device Description: Fisher Spoon and Needle 5-1/2", Double-Ended, 7x15mm Spoon and 33mm Long Needle
Catalog Number
18-568
Brand Name
Integra® Miltex®
Version/Model Number
18-568
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
-
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
HNB
Product Code Name
Spoon, ophthalmic
Public Device Record Key
425226b4-6237-4e03-838f-20a383598b0a
Public Version Date
February 05, 2020
Public Version Number
3
DI Record Publish Date
December 21, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15051 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4286 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 3 |