Duns Number:342228620
Catalog Number
-
Brand Name
Sterilizable Metal Sleeve
Version/Model Number
000000-0140-600
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HMW
Product Code Name
Drape, Microscope, Ophthalmic
Public Device Record Key
3d911276-4dc9-40ff-87b4-1e3c42d672ac
Public Version Date
November 22, 2018
Public Version Number
4
DI Record Publish Date
May 04, 2017
Package DI Number
04049539103284
Quantity per Package
2
Contains DI Package
04049539103536
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 14 |
2 | A medical device with a moderate to high risk that requires special controls. | 86 |
3 | A medical device with high risk that requires premarket approval | 1 |