Duns Number:811313428
Device Description: ATRAMAT PGC25 SURGICAL SUTURE UNDYED USP 5-0 EP 1, 45 CM NEEDLE HPE-11 ATRAGLIDE CUTTING 1 ATRAMAT PGC25 SURGICAL SUTURE UNDYED USP 5-0 EP 1, 45 CM NEEDLE HPE-11 ATRAGLIDE CUTTING 11 MM 3/8 CIRCLEPGC25 INCOLORO USP 5-0, 45 CM AGUJA HPE-11 CORTANTE ATRAGLIDE 11 MM 3/8 CIRCULO
Catalog Number
HPE1105-45B
Brand Name
ATRAMAT
Version/Model Number
PGC25
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
K072863,K072863
Product Code
GAM
Product Code Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Public Device Record Key
16981da9-3650-4b77-a5b6-2adb1b1046d3
Public Version Date
December 31, 2018
Public Version Number
2
DI Record Publish Date
July 11, 2018
Package DI Number
07500142157721
Quantity per Package
12
Contains DI Package
07500142057724
Package Discontinue Date
December 31, 2018
Package Status
Not 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 |