Duns Number:315018218
Device Description: ADTEC TC Needleholder complete instrument, curved to left, 16 1/2", (420 mm), diam. 5 mm, ADTEC TC Needleholder complete instrument, curved to left, 16 1/2", (420 mm), diam. 5 mm, non-sterile, reusable
Catalog Number
PL417R
Brand Name
ADTEC
Version/Model Number
PL417R
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
HXK
Product Code Name
HOLDER, NEEDLE; ORTHOPEDIC
Public Device Record Key
082f75a5-d024-40fc-989d-f8426d6ba7cd
Public Version Date
July 29, 2021
Public Version Number
3
DI Record Publish Date
April 23, 2020
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 | 11840 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7088 |
| 3 | A medical device with high risk that requires premarket approval | 37 |