DEVICE: ATRAMAT (07500142009518)
Device Identifier (DI) Information
ATRAMAT
POLIPROPILENO
In Commercial Distribution
SG3661-75
Internacional Farmacéutica, S.A. de C.V.
POLIPROPILENO
In Commercial Distribution
SG3661-75
Internacional Farmacéutica, S.A. de C.V.
ATRAMAT POLYPROPYLENE SURGICAL SUTURE BLUE USP 0 EP 3,5, 75 CM NEEDLE SG-36 PREMIUM HEAVY TAPER POINT 36 MM 1/2 CIRCLE
POLIPROPILENO AZUL USP 0, 75 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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Polyolefin suture, monofilament | A single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene, 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 needle intended to be disposed of after single use. 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 intended to be used in a sterile condition. |
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 60 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 BLUE |
Device Size Text, specify: ATRAMAT POLYPROPYLENE |
Device Size Text, specify: USP 0 |
Device Record Status
d9022a6e-379e-4d67-99d0-7765c2a2a732
February 07, 2019
6
October 14, 2016
February 07, 2019
6
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 |
---|---|---|---|---|---|
07500142109515 | 12 | 07500142009518 | 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