Duns Number:108631797
Catalog Number
2598-07-900
Brand Name
DePuy TSS Retractor Light Strip 5-Pack
Version/Model Number
012512
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FDG
Product Code Name
Retractor, Fiberoptic
Public Device Record Key
1d0fba02-6dee-4e48-b5f0-42e4d4079c09
Public Version Date
June 08, 2022
Public Version Number
1
DI Record Publish Date
May 31, 2022
Package DI Number
10812432022911
Quantity per Package
5
Contains DI Package
00812432022914
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 120 |
2 | A medical device with a moderate to high risk that requires special controls. | 4 |