DEVICE: ATRAMAT (07500142023651)
Device Identifier (DI) Information
ATRAMAT
PGA
In Commercial Distribution
SG3691-90
Internacional Farmacéutica, S.A. de C.V.
PGA
In Commercial Distribution
SG3691-90
Internacional Farmacéutica, S.A. de C.V.
ATRAMAT PGA SURGICAL SUTURE VIOLET USP 0 EP 3,5, 90 CM NEEDLE SG-36 PREMIUM HEAVY TAPER POINT 36 MM 1/2 CIRCLE
PGA VIOLETA USP 0, 90 CM AGUJA SG-36 AHUSADA GRUESA PREMIUM 36 MM 1/2 CIRCULO
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
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? |
---|---|---|---|---|
13908 | Polyglycolic acid suture |
A sterile, typically multiple-strand (multifilament), synthetic, bioabsorbable thread made from a polymerization of polyglycolic acid (PGA) that is intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. It may include an attached needle intended to be disposed of after single use; it may be coated with a material such as polycaprolactone or uncoated. The thread provides temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis. This is a single-use device.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K040282 | 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: 36 Millimeter |
Device Size Text, specify: 1/2 CIRCLE |
Device Size Text, specify: SUTURE VIOLET |
Device Size Text, specify: ATRAMAT PGA |
Device Size Text, specify: USP 0 |
Device Record Status
87a80ec5-2eb5-4027-b6f5-c6ab66fcdee1
July 11, 2018
5
September 29, 2016
July 11, 2018
5
September 29, 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 |
---|---|---|---|---|---|
07500142123658 | 12 | 07500142023651 | 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