DEVICE: ATRAMAT (07500142005800)

Device Identifier (DI) Information

ATRAMAT
PDX
In Commercial Distribution
SR1774
Internacional Farmacéutica, S.A. de C.V.
07500142005800
GS1
December 31, 2040
1
811313428 *Terms of Use
ATRAMAT PDX SURGICAL SUTURE VIOLET USP 4-0 EP 1,5, 70 CM NEEDLE SR-17 PREMIUM REGULAR TAPER POINT 17 MM 1/2 CIRCLE POLIDIOXANONA VIOLETA USP 4-0, 70 CM AGUJA SR-17 AHUSADA REGULAR PREMIUM 17 MM 1/2 CIRCULO
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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.
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FDA Product Code

[?]
Product Code Product Code Name
NEW Suture, Surgical, Absorbable, Polydioxanone
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K041048 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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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
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Clinically Relevant Size

[?]
Size Type Text
Length: 17 Millimeter
Device Size Text, specify: 1/2 CIRCLE
Device Size Text, specify: SUTURE VIOLET
Device Size Text, specify: ATRAMAT PDX
Device Size Text, specify: USP 4-0
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Device Record Status

070d739a-6083-4f49-8a30-4758a922ca20
July 06, 2018
4
October 18, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
07500142105807 12 07500142005800 2040-12-31 In Commercial Distribution DOZEN
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
+525511050260
ATENCION.CLIENTE@ATRAMAT.COM
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