Duns Number:313267265
Device Description: Chronoceptor for 2.0 and 2.5 Mecron Screws with length gauge 8-50 AO-connector color-coate Chronoceptor for 2.0 and 2.5 Mecron Screws with length gauge 8-50 AO-connector color-coated white and magenta sterile
Catalog Number
-
Brand Name
Chronoceptor™
Version/Model Number
CH15100S
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
LXH
Product Code Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Public Device Record Key
d4b76476-5149-4789-a0f2-9141346b464c
Public Version Date
September 19, 2022
Public Version Number
2
DI Record Publish Date
November 01, 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 | 328 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1327 |
| U | Unclassified | 13 |