DEVICE: ATRAMAT (07500142007507)
Device Identifier (DI) Information
ATRAMAT
SEDA
In Commercial Distribution
PU6032
Internacional Farmacéutica, S.A. de C.V.
SEDA
In Commercial Distribution
PU6032
Internacional Farmacéutica, S.A. de C.V.
ATRAMAT SILK SURGICAL SUTURE BLACK USP 2-0 EP 3, 75 CM NEEDLE PU-60 PREMIUM STRAIGHT CUTTING 60 MM STRAIGHT
SEDA NEGRA USP 2-0, 75 CM AGUJA PU-60 RECTA CORTANTE PREMIUM 60 MM RECTA
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.
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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: 60 Millimeter |
Device Size Text, specify: RECTA |
Device Size Text, specify: SUTURE BLACK |
Device Size Text, specify: ATRAMAT SILK |
Device Size Text, specify: USP 2-0 |
Device Record Status
d0948eca-f8d0-4b1f-b600-2e634f0b75e5
February 05, 2021
5
October 14, 2016
February 05, 2021
5
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 |
---|---|---|---|---|---|
07500142107504 | 12 | 07500142007507 | 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