Duns Number:081277700
Device Description: 27" SZ 4-0 PLAIN GUT ABS C-6 NEEDLE CIR REV CUT
Catalog Number
-
Brand Name
Miltex®
Version/Model Number
62506
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
K020597,K020597,K020597
Product Code
GAL
Product Code Name
SUTURE, ABSORBABLE, NATURAL
Public Device Record Key
7b08e749-92e3-4f8f-9ced-88a2a212c9c9
Public Version Date
February 05, 2021
Public Version Number
6
DI Record Publish Date
January 05, 2017
Package DI Number
10381780363859
Quantity per Package
12
Contains DI Package
00381780363852
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15051 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4286 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 3 |