Duns Number:811313428
Device Description: ATRAMAT PDX SURGICAL SUTURE VIOLET USP 5-0 EP 1, 45 CM NEEDLE HPE-13 ATRAGLIDE CUTTING 13 ATRAMAT PDX SURGICAL SUTURE VIOLET USP 5-0 EP 1, 45 CM NEEDLE HPE-13 ATRAGLIDE CUTTING 13 MM 3/8 CIRCLEPOLIDIOXANONA VIOLETA USP 5-0, 45 CM AGUJA HPE-13 CORTANTE ATRAGLIDE 13 MM 3/8 CIRCULO
Catalog Number
HPE1375-45
Brand Name
ATRAMAT
Version/Model Number
PDX
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
December 31, 2040
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
K041048,K041048
Product Code
NEW
Product Code Name
Suture, Surgical, Absorbable, Polydioxanone
Public Device Record Key
0fba9fe6-8607-462c-bb26-13e122e11d48
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
July 30, 2018
Package DI Number
07500142180484
Quantity per Package
12
Contains DI Package
07500142080487
Package Discontinue Date
December 31, 2040
Package Status
In Commercial Distribution
Package Type
DOZEN
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 44 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 830 |