Duns Number:811313428
Device Description: ATRAMAT PGLA90 SURGICAL SUTURE UNDYED USP 5-0 EP 1, 45 CM NEEDLE HPE-16 ATRAGLIDE CUTTING ATRAMAT PGLA90 SURGICAL SUTURE UNDYED USP 5-0 EP 1, 45 CM NEEDLE HPE-16 ATRAGLIDE CUTTING 16 MM 3/8 CIRCLEPGLA90 INCOLORO USP 5-0, 45 CM AGUJA HPE-16 CORTANTE ATRAGLIDE 16 MM 3/8 CIRCULO
Catalog Number
HPE16305-45B
Brand Name
ATRAMAT
Version/Model Number
PGLA90
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
17c4cd59-7aab-46b7-b168-0a14d0681833
Public Version Date
August 13, 2018
Public Version Number
1
DI Record Publish Date
July 13, 2018
Package DI Number
07500142157141
Quantity per Package
12
Contains DI Package
07500142057144
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 |