DEVICE: ATRAMAT (07500142009983)
Device Identifier (DI) Information
ATRAMAT
POLIDIOXANONA
In Commercial Distribution
00998
Internacional Farmacéutica, S.A. de C.V.
POLIDIOXANONA
In Commercial Distribution
00998
Internacional Farmacéutica, S.A. de C.V.
POLIDIOXANONA VIOLETA USP 3-0, 45 CM AGUJA PE-24 REVERSO CORTANTE PREMIUM 24 MM 3/8 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 |
---|---|
Polydioxanone suture | A sterile, single-strand (monofilament), synthetic, bioabsorbable thread made of polydioxanone (PDS) [made from poly (p-dioxanone)] intended to join (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 extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NEW | Suture, Surgical, Absorbable, Polydioxanone |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
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: 24 Millimeter |
Device Record Status
ed2aa551-1b40-49a0-b777-8148dfd865b1
March 29, 2018
2
October 02, 2016
March 29, 2018
2
October 02, 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 |
---|---|---|---|---|---|
17500142009983 | 12 | 07500142009983 | 2029-10-02 | In Commercial Distribution |
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