Duns Number:315018218
Device Description: MIASPAS MINI-TTA Rib Retractor Blade, Size S, depth: 23 mm, width: 25 mm, titanium, with b MIASPAS MINI-TTA Rib Retractor Blade, Size S, depth: 23 mm, width: 25 mm, titanium, with ball snap closure, non-sterile, reusable
Catalog Number
BV162T
Brand Name
AESCULAP
Version/Model Number
BV162T
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 03, 2021
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
HRX
Product Code Name
Arthroscope
Public Device Record Key
812e0f7e-0a24-4028-8dc4-132a65c63459
Public Version Date
May 28, 2021
Public Version Number
2
DI Record Publish Date
May 06, 2020
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 | 11840 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7088 |
| 3 | A medical device with high risk that requires premarket approval | 37 |