Duns Number:801895244
Device Description: Medium-Large; 10-15 cm Incision Range
Catalog Number
-
Brand Name
Mobius Elastic Retractor
Version/Model Number
900-517
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"
Yes
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
K050256,K050256
Product Code
GAD
Product Code Name
Retractor
Public Device Record Key
51ce25a0-e61e-477a-b3ea-d97a3cb4b3c5
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 07, 2016
Package DI Number
20888937003813
Quantity per Package
5
Contains DI Package
00888937003819
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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1471 |
| 3 | A medical device with high risk that requires premarket approval | 2 |