DEVICE: ATRAMAT (07500142008337)

Device Identifier (DI) Information

ATRAMAT
POLIESTER
In Commercial Distribution
EA855/2-45B
Internacional Farmacéutica, S.A. de C.V.
07500142008337
GS1
December 31, 2040
1
811313428 *Terms of Use
ATRAMAT POLYESTER SURGICAL SUTURE WHITE USP 5-0 EP 1, 45 CM DOUBLE NEEDLE EA-8 PREMIUM SPATULA 8 MM 1/4 CIRCLE POLIESTER BLANCO USP 5-0, 45 CM DOBLE AGUJA EA-8 ESPATULADA PREMIUM 8 MM 1/4 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
Polyester suture A sterile, multiple-strand (multifilament), synthetic, non-bioabsorbable thread made of polyester (a polymer of polyethylene terephthalate) fibres, that may be coated (e.g., with polybutilate/silicone), intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may also include an attached disposable needle or preloaded pledget for enhanced support. It is commonly used for vessel anastomosis and the placement of prosthetic materials, and provides temporary wound support until the wound sufficiently heals to withstand normal stress; it elicits minimal tissue reaction and lasts indefinitely in the body. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
GAS Suture, Nonabsorbable, Synthetic, Polyester
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K905285 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Handling 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: 8 Millimeter
Device Size Text, specify: 1/4 CIRCLE
Device Size Text, specify: SUTURE WHITE
Device Size Text, specify: ATRAMAT POLIESTER
Device Size Text, specify: USP 5-0
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Device Record Status

225368e7-fba9-4248-9831-4ef70c6419f1
July 11, 2018
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
07500142108334 12 07500142008337 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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