Duns Number:025460908
Device Description: OLSEN HEGAR NEEDLE HOLDER 5.5
Catalog Number
DYND04123
Brand Name
MEDLINE
Version/Model Number
DYND04123
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"
Yes
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
GEN
Product Code Name
FORCEPS, GENERAL & PLASTIC SURGERY
Public Device Record Key
f3a042e4-9072-45fb-9550-d44536e9ff69
Public Version Date
January 10, 2022
Public Version Number
1
DI Record Publish Date
January 01, 2022
Package DI Number
40888277557322
Quantity per Package
50
Contains DI Package
10888277557321
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |