Duns Number:315018218
Device Description: Wire Cutting Forceps, f.wire remov:after sternum sut, 6 3/4", (170 mm), slender pattern, s Wire Cutting Forceps, f.wire remov:after sternum sut, 6 3/4", (170 mm), slender pattern, special hardened cutting edges, soft wire up to Ø 0.9 mm, non-sterile, reusable
Catalog Number
LX149R
Brand Name
AESCULAP
Version/Model Number
LX149R
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
c1f67a1e-cac6-46cc-b41f-a98e96f0a621
Public Version Date
May 14, 2020
Public Version Number
1
DI Record Publish Date
May 06, 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 |