Duns Number:015272206
Device Description: Lacrimal intubation set, straight tip, 23 gauge x 7'', packaged individually, sterile, dis Lacrimal intubation set, straight tip, 23 gauge x 7'', packaged individually, sterile, disposable, box of 3
Catalog Number
585010
Brand Name
Ambler Surgical
Version/Model Number
Lacrimal intubation set
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
HNL
Product Code Name
Probe, lachrymal
Public Device Record Key
45b3b711-faca-4205-9735-e6f376d80d1d
Public Version Date
January 12, 2021
Public Version Number
1
DI Record Publish Date
January 04, 2021
Package DI Number
00190660199593
Quantity per Package
3
Contains DI Package
10190660199590
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 |