DEVICE: ATRAMAT (07500142001116)

Device Identifier (DI) Information

ATRAMAT
POLIPROPILENO
In Commercial Distribution
S2563/2
Internacional Farmacéutica, S.A. de C.V.
07500142001116
GS1
December 31, 2040
1
811313428 *Terms of Use
ATRAMAT POLYPROPYLENE SURGICAL SUTURE BLUE USP 3-0 EP 2, 90 CM DOUBLE NEEDLE S-25 PREMIUM TAPER POINT 25 MM 1/2 CIRCLE POLIPROPILENO AZUL USP 3-0, 90 CM DOBLE AGUJA S-25 AHUSADA PREMIUM 25 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
Polyolefin suture, monofilament A single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene, polytetrafluoroethylene, polyvinylidene fluoride) 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 needle intended to be disposed of after single use. 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 intended to be used in a sterile condition.
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FDA Product Code

[?]
Product Code Product Code Name
GAW Suture, Nonabsorbable, Synthetic, Polypropylene
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K911189 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: 25 Micrometer
Device Size Text, specify: 1/2 CIRCLE
Device Size Text, specify: SUTURE BLUE
Device Size Text, specify: ATRAMAT POLYPROPYLENE
Device Size Text, specify: USP 3-0
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Device Record Status

666178a2-848c-4f2d-9fee-a2e7544ce76f
February 07, 2019
5
September 28, 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
07500142101113 12 07500142001116 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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