DEVICE: ATRAMAT (07500142029806)

Device Identifier (DI) Information

ATRAMAT
PDX
In Commercial Distribution
02980
Internacional Farmacéutica, S.A. de C.V.
07500142029806
GS1
October 29, 2029
1
811313428 *Terms of Use
POLIDIOXANONA VIOLETA USP 1, 70 CM AGUJA SG-36 AHUSADA GRUESA PREMIUM 36 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
Polydioxanone suture A sterile, single-strand (monofilament), synthetic, bioabsorbable thread made of polydioxanone (PDS) [made from poly (p-dioxanone)] 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 extended 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
NEW Suture, Surgical, Absorbable, Polydioxanone
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

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: 36 Millimeter
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Device Record Status

b7625846-62f2-4f96-aa06-cc5f0f4efca6
March 29, 2018
2
October 16, 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
17500142029806 12 07500142029806 2029-10-29 In Commercial Distribution
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Secondary DI

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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
CUSTOMER.CARE@ATRAMAT.COM
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