DEVICE: ATRAMAT (07500142012952)
Device Identifier (DI) Information
ATRAMAT
POLIPROPILENO
In Commercial Distribution
PE2463
Internacional Farmacéutica, S.A. de C.V.
POLIPROPILENO
In Commercial Distribution
PE2463
Internacional Farmacéutica, S.A. de C.V.
ATRAMAT POLYPROPYLENE SURGICAL SUTURE BLUE USP 3-0 EP 2, 45 CM NEEDLE PE-24 PREMIUM REVERSE CUTTING 24 MM 3/8 CIRCLE
POLIPROPILENO AZUL USP 3-0, 45 CM AGUJA PE-24 REVERSO CORTANTE PREMIUM 24 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? |
---|---|---|---|---|
13909 | Polyolefin/fluoropolymer suture, monofilament |
A single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene) or fluoropolymer (e.g., polytetrafluoroethylene, polyvinylidene fluoride) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. 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 |
---|---|
GAW | Suture, Nonabsorbable, Synthetic, Polypropylene |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K911189 | 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: 24 Millimeter |
Device Size Text, specify: SUTURE BLUE |
Device Size Text, specify: 3/8 CIRCLE |
Device Size Text, specify: ATRAMAT POLYPROPYLENE |
Device Size Text, specify: USP 3-0 |
Device Record Status
57bca21b-fe66-4a50-a217-c2d48b024661
June 02, 2023
7
October 17, 2016
June 02, 2023
7
October 17, 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 |
---|---|---|---|---|---|
07500142112959 | 12 | 07500142012952 | 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