DEVICE: ATRAMAT (07500142004735)
Device Identifier (DI) Information
ATRAMAT
PDX
In Commercial Distribution
S1675/2
Internacional Farmacéutica, S.A. de C.V.
PDX
In Commercial Distribution
S1675/2
Internacional Farmacéutica, S.A. de C.V.
ATRAMAT PDX SURGICAL SUTURE VIOLET USP 5-0 EP 1, 75 CM DOUBLE NEEDLE S-16 PREMIUM TAPER POINT 16 MM 1/2 CIRCLE
POLIDIOXANONA VIOLETA USP 5-0, 75 CM DOBLE AGUJA S-16 AHUSADA PREMIUM 16 MM 1/2 CIRCULO
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
16584 | Polyester suture, bioabsorbable, monofilament, non-antimicrobial |
A single-strand (monofilament), synthetic, bioabsorbable thread made from a polyester (e.g., polydioxanone, poliglecaprone, polycaprolactone, polyglyconate, polyhydroxybutyrate) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NEW | Suture, Surgical, Absorbable, Polydioxanone |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K041048 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 15 and 30 Degrees Celsius |
Storage Environment Humidity: between 0 and 65 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 16 Millimeter |
Device Size Text, specify: 1/2 CIRCLE |
Device Size Text, specify: SUTURE VIOLET |
Device Size Text, specify: ATRAMAT PDX |
Device Size Text, specify: USP 5-0 |
Device Record Status
c88d5edf-a5b3-4aa3-99a2-f83f3bb9ffa0
February 05, 2021
7
September 28, 2016
February 05, 2021
7
September 28, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
07500142104732 | 12 | 07500142004735 | 2040-12-31 | In Commercial Distribution | DOZEN |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+5255111050260
ATENCION.CLIENTE@ATRAMAT.COM
ATENCION.CLIENTE@ATRAMAT.COM