Duns Number:756138509
Catalog Number
ENDOPROBE ST ILLUMINA 20G,
Brand Name
ACC. PROBE, ENDO.ST ILLUMINA 20G,
Version/Model Number
A527100
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K050807,K050807
Product Code
HQF
Product Code Name
Laser, Ophthalmic
Public Device Record Key
17f2ba39-0484-44d9-a5b7-b14e46c3e277
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 21, 2017
Package DI Number
09342395000779
Quantity per Package
10
Contains DI Package
09342395002001
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 62 |