Duns Number:315018218
Device Description: TC Wire Cutting Scissors, angled on flat, 5 1/2", (140 mm), lateral cutting, hard wire up TC Wire Cutting Scissors, angled on flat, 5 1/2", (140 mm), lateral cutting, hard wire up to Ø 1.0 mm, soft wire up to Ø 1.5 mm, non-sterile, reusable
Catalog Number
DP530R
Brand Name
AESCULAP
Version/Model Number
DP530R
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
HXZ
Product Code Name
CUTTER, WIRE
Public Device Record Key
94d9ce25-32e2-407c-afcf-4f138b33a121
Public Version Date
April 28, 2020
Public Version Number
1
DI Record Publish Date
April 20, 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 |