Duns Number:257382580
Device Description: The Needle-Holder is an instrument intended to hold the suturing needle for the closing of The Needle-Holder is an instrument intended to hold the suturing needle for the closing of incisions. It locks when it grips the needle or thread. All non-glare, except for the closure mechanism. This instrument is usually not used at the same time as the laser.
Catalog Number
-
Brand Name
Castroviejo Needle Holder (curved) (non glare)
Version/Model Number
25-014
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"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MDM
Product Code Name
Instrument, Manual, Surgical, General Use
Public Device Record Key
a1c59a56-f5ad-45e2-b7c1-32a0c32144d6
Public Version Date
January 08, 2021
Public Version Number
2
DI Record Publish Date
November 21, 2019
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 | 192 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 88 |