DEVICE: ATRAMAT (07500142005046)
Device Identifier (DI) Information
ATRAMAT
POLYESTER
In Commercial Distribution
S1652/2-75KP6
Internacional Farmacéutica, S.A. de C.V.
POLYESTER
In Commercial Distribution
S1652/2-75KP6
Internacional Farmacéutica, S.A. de C.V.
ATRAMAT POLYESTER SURGICAL SUTURE GREEN USP 2-0 EP 3, 75 CM DOUBLE NEEDLE S-16 PREMIUM TAPER POINT 16 MM 1/2 CIRCLE KIT WITH PLEDGET WITH 6 POUCHES
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? |
---|---|---|---|---|
13906 | Polyester suture, non-bioabsorbable, multifilament |
A multiple-strand (multifilament), synthetic thread made from a non-bioabsorbable polyester 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 |
---|---|
GAS | Suture, Nonabsorbable, Synthetic, Polyester |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K905285 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Humidity: between 0 and 65 Percent (%) Relative Humidity |
Storage Environment Temperature: between 15 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 16 Millimeter |
Device Size Text, specify: USP 2-0 EP 3 |
Device Record Status
1e816984-3a2b-4ad9-958a-d68407fa7e0d
March 16, 2021
1
March 08, 2021
March 16, 2021
1
March 08, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
07500142905049 | 60 | 07500142005046 | 2040-12-31 | In Commercial Distribution | BOX WITH 60 PACKS |
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
CUSTOMER.CARE@ATRAMAT.COM
CUSTOMER.CARE@ATRAMAT.COM