Duns Number:482661753
Device Description: FREE NEEDLE LOOP REVERSE CUTTING NEEDLE WITH STAINLESS STEEL WIRE LOOP 36mm 1/2 c REVERSE FREE NEEDLE LOOP REVERSE CUTTING NEEDLE WITH STAINLESS STEEL WIRE LOOP 36mm 1/2 c REVERSE CUTTING N=1 OS-6
Catalog Number
223173
Brand Name
NA
Version/Model Number
223173
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
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
GAB
Product Code Name
NEEDLE, SUTURING, DISPOSABLE
Public Device Record Key
b1c68b6b-a926-4aee-ae91-91734112dc3c
Public Version Date
December 04, 2020
Public Version Number
4
DI Record Publish Date
July 29, 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 | 972 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6382 |
| 3 | A medical device with high risk that requires premarket approval | 20 |
| U | Unclassified | 20 |