Duns Number:535040901
Device Description: Unicryl M 25mm 1/2c.r.b. 2(3/0) 75cm, Monofilament Poly(p-dioxanone), Synthetic Absorbable Unicryl M 25mm 1/2c.r.b. 2(3/0) 75cm, Monofilament Poly(p-dioxanone), Synthetic Absorbable Surgical Sutures / Ligatures.
Catalog Number
SD10036
Brand Name
UNICRYL M
Version/Model Number
SD10036
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K042285,K042285
Product Code
NEW
Product Code Name
Suture, Surgical, Absorbable, Polydioxanone
Public Device Record Key
90c369de-39a4-4904-bb27-3e20d318fb98
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
April 30, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |