Duns Number:008124539
Device Description: Replacement straps for Standard Slings; pair per pack
Catalog Number
-
Brand Name
Replacement Straps
Version/Model Number
10754
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
-
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
FSA
Product Code Name
Lift, Patient, Non-Ac-Powered
Public Device Record Key
abdf70ed-fbfd-489a-9216-2e654b40b13e
Public Version Date
April 27, 2021
Public Version Number
1
DI Record Publish Date
April 19, 2021
Package DI Number
00616784075440
Quantity per Package
12
Contains DI Package
00616784075419
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |