DEVICE: ATRAMAT (07500142013157)
Device Identifier (DI) Information
ATRAMAT
SEDA
In Commercial Distribution
PE1934-45
Internacional Farmacéutica, S.A. de C.V.
SEDA
In Commercial Distribution
PE1934-45
Internacional Farmacéutica, S.A. de C.V.
ATRAMAT SILK SURGICAL SUTURE BLACK USP 4-0 EP 1,5, 45 CM NEEDLE PE-19 PREMIUM REVERSE CUTTING 19 MM 3/8 CIRCLE
SEDA NEGRA USP 4-0, 45 CM AGUJA PE-19 REVERSO CORTANTE PREMIUM 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? |
---|---|---|---|---|
13910 | Silk suture |
A natural, non-bioabsorbable thread made from raw silk spun by silkworms (typically coated with beeswax or silicone) 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. It provides temporary wound support until the wound sufficiently heals to withstand normal stress. Although classified as a "non-bioabsorbable" material, it may be digested by proteolysis after an extended period of time. This is a single-use device.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GAP | Suture, Nonabsorbable, Silk |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K905287 | 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 BLACK |
Device Size Text, specify: ATRAMAT SILK |
Device Size Text, specify: USP 4-0 |
Device Record Status
c6fcd6d1-9250-467b-a634-10f0388619e1
February 05, 2021
5
October 17, 2016
February 05, 2021
5
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 |
---|---|---|---|---|---|
07500142113154 | 12 | 07500142013157 | 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