Duns Number:602465783
Device Description: CERVICAL SA GUIDED ANGLED AWL, 10 mm
Catalog Number
-
Brand Name
IdentiTi
Version/Model Number
135-3300-100
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
HWJ
Product Code Name
AWL
Public Device Record Key
245efc69-331d-4a5e-b630-2b8e6d09ed4c
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
December 05, 2021
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 | 5644 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 26570 |
| U | Unclassified | 15 |