DEVICE: ATRAMAT (07500142024023)

Device Identifier (DI) Information

ATRAMAT
PGC25
In Commercial Distribution
P-PE1904-45B
Internacional Farmacéutica, S.A. de C.V.
07500142024023
GS1
December 31, 2040
1
811313428 *Terms of Use
ATRAMAT PGC25 SURGICAL SUTURE UNDYED USP 4-0 EP 1,5, 45 CM NEEDLE P-PE-19 SUPRA-SHARP REVERSE CUTTING 19 MM 3/8 CIRCLE PGC25 INCOLORO USP 4-0, 45 CM AGUJA P-PE-19 REVERSO CORTANTE SUPRA-SHARP 19 MM 3/8 CIRCULO
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
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
Poliglecaprone suture A sterile, single-strand (monofilament), synthetic, bioabsorbable thread made of poliglecaprone (a copolymer of glycolide and E-caprolactone of low tissue reactivity) 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 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 [?]
K072863 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: 19 Millimeter
Device Size Text, specify: 3/8 CIRCLE
Device Size Text, specify: SUTURE UNDYED
Device Size Text, specify: ATRAMAT PGC25
Device Size Text, specify: USP 4-0
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Device Record Status

c9a08574-1d0b-47c6-a452-2d9f8a47e6f5
July 11, 2018
5
September 27, 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
07500142124020 12 07500142024023 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

[?]
+525511050206
ATENCION.CLIENTE@ATRAMAT.COM
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