DEVICE: MANI Sutures Polyester (04546951402181)

Device Identifier (DI) Information

MANI Sutures Polyester
2863
In Commercial Distribution
2863
MANI, INC.
04546951402181
GS1

1
690622428 *Terms of Use
MANI Ophthalmic Sutures
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Device Characteristics

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

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Polyester suture, non-bioabsorbable, multifilament A multiple-strand (multifilament), synthetic thread made from a non-bioabsorbable polyester 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

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Product Code Product Code Name
GAT Suture, Nonabsorbable, Synthetic, Polyethylene
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K050150 000
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Suture Length 45cm
Device Size Text, specify: Needle Length 6.0mm
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Device Record Status

a10da645-359d-4eb3-b32e-9c2721c9f11f
February 07, 2019
4
June 04, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
14546951402188 12 04546951402181 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

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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
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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