Duns Number:015272206
Device Description: Honan balloon 3 boxes of 12 (36 total) single use disposable bellows and headbands, latex Honan balloon 3 boxes of 12 (36 total) single use disposable bellows and headbands, latex free
Catalog Number
6271E
Brand Name
Ambler Surgical
Version/Model Number
6271E
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
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
K820526
Product Code
LCC
Product Code Name
Applicator, ocular pressure
Public Device Record Key
896335f4-cb2d-4b79-9925-cd9daf493d6a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 29, 2016
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 | 14984 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3118 |