DEVICE: ATRAMAT (07500142000843)

Device Identifier (DI) Information

ATRAMAT
SILK
In Commercial Distribution
CE2632
Internacional Farmacéutica, S.A. de C.V.
07500142000843
GS1
December 31, 2040
1
811313428 *Terms of Use
ATRAMAT SILK SURGICAL SUTURE BLACK USP 2-0 EP 3, 75 CM NEEDLE CE-26 REVERSE CUTTING 26 MM 3/8 CIRCLE
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
13910 Silk suture
A natural, non-bioabsorbable thread made from raw silk spun by silkworms (typically coated with beeswax or silicone) 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 disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It provides temporary wound support until the wound sufficiently heals to withstand normal stress. Although classified as a "non-bioabsorbable" material, it may be digested by proteolysis after an extended period of time. This is a single-use device.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
GAP Suture, Nonabsorbable, Silk
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K905287 000
No CLOSE

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: USP 2-0 EP 3
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Device Record Status

80f656df-dc42-4e66-bd2b-5af6a62a8897
March 16, 2021
1
March 08, 2021
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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
07500142100840 12 07500142000843 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
CUSTOMER.CARE@ATRAMAT.COM
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