DEVICE: Monoplus (04046963761875)

Device Identifier (DI) Information

Monoplus
G0024897
Not in Commercial Distribution
G0024897
B BRAUN SURGICAL SA
04046963761875
GS1
January 24, 2018
12
511268005 *Terms of Use
MONOPLUS VIOL. 0 (3,5) 70CM 2XGR65 (M)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
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
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Length: 70.00 Centimeter
Device Size Text, specify: Size of Thread (USP - Others) : 0
Device Size Text, specify: Thread Material : polydioxanone
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Device Record Status

96dce6b1-c697-4e3c-8546-d8393eb00c1c
June 21, 2018
3
August 19, 2015
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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
No Package DIs found
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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: 04045439044641 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)282-9000
GUDID.BBMUS_Service@bbraun.com
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