Duns Number:603420183
Device Description: RD® QUICK LOAD® SUTURE - 2-0 MONOGLIDE®, Sterile, Synthetic, Polydioxanone, Absorbable, Mo RD® QUICK LOAD® SUTURE - 2-0 MONOGLIDE®, Sterile, Synthetic, Polydioxanone, Absorbable, Monofilament, Surgical Suture, USP, 3.0 Metric, 53", 135 cm, PurpleBase Package Type - Pouch / Each
Catalog Number
021030
Brand Name
RD® QUICK LOAD®
Version/Model Number
021030
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
K031443,K031443
Product Code
NEW
Product Code Name
Suture, Surgical, Absorbable, Polydioxanone
Public Device Record Key
502e047e-a7b6-494e-8db1-daf922c41ed2
Public Version Date
February 05, 2021
Public Version Number
7
DI Record Publish Date
December 04, 2015
Package DI Number
10850200006183
Quantity per Package
12
Contains DI Package
00850200006186
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box / Inner Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 56 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 31 |