DEVICE: ATRAMAT (07500142010040)
Device Identifier (DI) Information
ATRAMAT
PDX
In Commercial Distribution
SR1376
Internacional Farmacéutica, S.A. de C.V.
PDX
In Commercial Distribution
SR1376
Internacional Farmacéutica, S.A. de C.V.
ATRAMAT PDX SURGICAL SUTURE VIOLET USP 6-0 EP 0.7, 70 CM NEEDLE SR-13 PREMIUM REGULAR TAPER POINT 13 MM 1/2 CIRCLE
POLIDIOXANONA VIOLETA USP 6-0, 70 CM AGUJA SR-13 AHUSADA REGULAR PREMIUM 13 MM 1/2 CIRCULO
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Polyester suture, bioabsorbable, monofilament | 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 needle. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device intended to be used in a sterile condition. |
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: 13 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 6-0 |
Device Record Status
770b2c07-3cd3-47bc-9c44-504e85510408
February 07, 2019
5
October 16, 2016
February 07, 2019
5
October 16, 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 |
---|---|---|---|---|---|
07500142110047 | 12 | 07500142010040 | 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