Duns Number:832696038
Device Description: CRAWFORD LACRIMAL INTUBATION SET, TWO OLIVE TIP PROBES .6MM DIA X 150MM LG ATTACHED TO 300 CRAWFORD LACRIMAL INTUBATION SET, TWO OLIVE TIP PROBES .6MM DIA X 150MM LG ATTACHED TO 300MM LG SILIC TBE
Catalog Number
OP0918-851
Brand Name
V. Mueller
Version/Model Number
OP0918-851
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
-
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
ae3d1898-de54-4672-b309-80ae149e1091
Public Version Date
December 11, 2019
Public Version Number
2
DI Record Publish Date
September 05, 2018
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 | 8016 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6223 |