DEVICE: ATRAMAT (07500142017377)

Device Identifier (DI) Information

ATRAMAT
POLIPROPILENO
In Commercial Distribution
SR2663-75
Internacional Farmacéutica, S.A. de C.V.
07500142017377
GS1
December 31, 2040
1
811313428 *Terms of Use
ATRAMAT POLYPROPYLENE SURGICAL SUTURE BLUE USP 3-0 EP 2, 75 CM NEEDLE SR-26 PREMIUM REGULAR TAPER POINT 26 MM 1/2 CIRCLE POLIPROPILENO AZUL USP 3-0, 75 CM AGUJA SR-26 AHUSADA REGULAR PREMIUM 26 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
Polypropylene suture A sterile, single-strand (monofilament), synthetic, non-bioabsorbable thread made of polypropylene, an isostatic crystalline stereoisomer of a linear propylene polymer, 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; as the material does not adhere to tissues, it is typically used in cases where the suture is to be removed after healing. This is a single-use device.
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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 Humidity: between 0 and 65 Percent (%) Relative Humidity
Storage Environment Temperature: between 15 and 30 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Length: 26 Millimeter
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

8f1b171c-08d3-4ad9-b061-5f507840583d
July 06, 2018
4
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
07500142117374 12 07500142017377 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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