Duns Number:763408366
Device Description: A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcler
Catalog Number
S5.2005U
Brand Name
Scleral buckling device, non-bioabsorbable
Version/Model Number
BAND (2.5 x 0.6 mm) TYPE 240
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HQX
Product Code Name
Implant, Orbital, Extra-Ocular
Public Device Record Key
02a33587-de5b-4dfa-9f8e-8515d378d506
Public Version Date
December 22, 2021
Public Version Number
2
DI Record Publish Date
March 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 | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 291 |
| U | Unclassified | 60 |