DEVICE: ATRAMAT (07500142057014)
Device Identifier (DI) Information
ATRAMAT
PGC25
In Commercial Distribution
HPE1903-45B
Internacional Farmacéutica, S.A. de C.V.
PGC25
In Commercial Distribution
HPE1903-45B
Internacional Farmacéutica, S.A. de C.V.
ATRAMAT PGC25 SURGICAL SUTURE UNDYED USP 3-0 EP 2, 45 CM NEEDLE HPE-19 ATRAGLIDE CUTTING 19 MM 3/8 CIRCLE
PGC25 INCOLORO USP 3-0, 45 CM AGUJA HPE-19 CORTANTE ATRAGLIDE 19 MM 3/8 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? |
---|---|---|---|---|
45814 | Poliglecaprone suture |
A sterile, single-strand (monofilament), synthetic, bioabsorbable thread made of poliglecaprone (a copolymer of glycolide and E-caprolactone of low tissue reactivity) 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. 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 [?] |
---|---|
K072863 | 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: 19 Millimeter |
Device Size Text, specify: 3/8 CIRCLE |
Device Size Text, specify: SUTURE UNDYED |
Device Size Text, specify: ATRAMAT PGC25 |
Device Size Text, specify: USP 3-0 |
Device Record Status
4409585c-e408-48c0-8cec-e8d8f5556401
July 06, 2018
4
October 18, 2016
July 06, 2018
4
October 18, 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 |
---|---|---|---|---|---|
07500142157011 | 12 | 07500142057014 | 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