Duns Number:015272206
Device Description: Irrigating cystotome, 27 gauge x 5/8'', vaulted side-cut, packaged individually, sterile, Irrigating cystotome, 27 gauge x 5/8'', vaulted side-cut, packaged individually, sterile, disposable, box of 10
Catalog Number
131609
Brand Name
Ambler Surgical
Version/Model Number
Irrigating cystotome
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
HNY
Product Code Name
Cystotome
Public Device Record Key
1645cf78-ad7e-436d-bcfa-2c88a79a9e36
Public Version Date
January 12, 2021
Public Version Number
1
DI Record Publish Date
January 04, 2021
Package DI Number
00190660198923
Quantity per Package
10
Contains DI Package
10190660198920
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 14984 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3118 |