Duns Number:315018218
Device Description: HEGAR-MAYO DUROGRIP TC Needleholder, straight, 9 1/4", (235 mm), with 0.5 mm pitch of serr HEGAR-MAYO DUROGRIP TC Needleholder, straight, 9 1/4", (235 mm), with 0.5 mm pitch of serration, suture up to 3/0, non-sterile, reusable
Catalog Number
BM068R
Brand Name
DUROGRIP
Version/Model Number
BM068R
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
8723e53e-58d6-49e6-a2ad-16575a4624c5
Public Version Date
January 08, 2021
Public Version Number
2
DI Record Publish Date
July 07, 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 |