DEVICE: ATRAMAT (07500142020612)
Device Identifier (DI) Information
ATRAMAT
PGLA90
In Commercial Distribution
SR17304-75
Internacional Farmacéutica, S.A. de C.V.
PGLA90
In Commercial Distribution
SR17304-75
Internacional Farmacéutica, S.A. de C.V.
ATRAMAT PGLA90 SURGICAL SUTURE VIOLET USP 4-0 EP 1,5, 75 CM NEEDLE SR-17 PREMIUM REGULAR TAPER POINT 17 MM 1/2 CIRCLE
PGLA90 VIOLETA USP 4-0, 75 CM AGUJA SR-17 AHUSADA REGULAR PREMIUM 17 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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
17471 | Polyester suture, bioabsorbable, multifilament, non-antimicrobial |
A multiple-strand (multifilament), synthetic, bioabsorbable thread made from a polyester 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 |
---|---|
GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K072859 | 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: 17 Millimeter |
Device Size Text, specify: 1/2 CIRCLE |
Device Size Text, specify: SUTURE VIOLET |
Device Size Text, specify: ATRAMAT PGLA90 |
Device Size Text, specify: USP 4-0 |
Device Record Status
23d67a9c-0298-4222-96d5-8f2731d8b5e5
February 05, 2021
7
October 14, 2016
February 05, 2021
7
October 14, 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 |
---|---|---|---|---|---|
07500142120619 | 12 | 07500142020612 | 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
[?]
+525511050260
ATENCION.CLIENTE@ATRAMAT.COM
ATENCION.CLIENTE@ATRAMAT.COM