Duns Number:809555139
Device Description: Xpand NT Iris Speculum, 6.7mm, Multi-Use
Catalog Number
-
Brand Name
Xpand
Version/Model Number
146701
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
HOC
Product Code Name
Clip, Iris Retractor
Public Device Record Key
f79eed72-4959-4816-9ac3-bc7a45c5d314
Public Version Date
November 01, 2019
Public Version Number
1
DI Record Publish Date
October 24, 2019
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 | 475 |
U | Unclassified | 13 |