Duns Number:312546955
Device Description: Depth comparison instrument Ø Screw1.7 - 2.5 mm, Ø probe 1.2 mm, M1, Depth comparison instrument Ø Screw1.7 - 2.5 mm, Ø probe 1.2 mm, M1, Range 0 - 50 mm
Catalog Number
27-08034
Brand Name
MONDEAL
Version/Model Number
27-08034
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2021
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
-
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
ddf86282-58e5-4306-9610-4b70d0a48208
Public Version Date
March 22, 2022
Public Version Number
2
DI Record Publish Date
July 07, 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 | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 565 |