DEVICE: ATRAMAT (07500142057496)

Device Identifier (DI) Information

ATRAMAT
PGA
In Commercial Distribution
P-PE1394-45B
Internacional Farmacéutica, S.A. de C.V.
07500142057496
GS1
December 31, 2040
1
811313428 *Terms of Use
ATRAMAT PGA SURGICAL SUTURE UNDYED USP 4-0 EP 1,5, 45 CM NEEDLE P-PE-13 SUPRA-SHARP REVERSE CUTTING 13 MM 3/8 CIRCLE PGA INCOLORO USP 4-0, 45 CM AGUJA P-PE-13 REVERSO CORTANTE SUPRA-SHARP 13 MM 3/8 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
Polyglycolic acid suture A sterile, typically multiple-strand (multifilament), synthetic, bioabsorbable thread made from a polymerization of polyglycolic acid (PGA) that is 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; it may be coated with a material such as polycaprolactone or uncoated. The thread provides 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
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K040282 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: 13 Millimeter
Device Size Text, specify: 3/8 CIRCLE
Device Size Text, specify: SUTURE UNDYED
Device Size Text, specify: ATRAMAT PGA
Device Size Text, specify: USP 4-0
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Device Record Status

efb622d6-633f-4a6e-81e6-8cb62eaaca74
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
07500142157493 12 07500142057496 2040-12-31 In Commercial Distribution DOZEN
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Secondary DI

[?]
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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