DEVICE: PDS (10705031048843)

Device Identifier (DI) Information

PDS
PDPB358T
In Commercial Distribution
PDPB358T
ETHICON, LLC
10705031048843
GS1

1
079402290 *Terms of Use
Antibacterial Violet Monofilament (Polydioxanone), Absorbable Surgical Suture
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Device Characteristics

MR Safe
No
No
Yes
Yes
No
No
Yes
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
47362 Polyester suture, bioabsorbable, monofilament, antimicrobial
A single-strand (monofilament), synthetic, bioabsorbable thread made from a polyester and containing an agent to locally inhibit bacterial growth, intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It is not a barbed suture. This is a single-use device.
Active true
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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 [?]
K061037 000
K212380 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: less than 86 Degrees Fahrenheit
Storage Environment Temperature: less than 30 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

345ca877-8023-4810-8f6e-3d3418ccffd8
May 17, 2023
6
September 01, 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
30705031048847 24 10705031048843 In Commercial Distribution BOX
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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
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(877)384-4266
xxx@xxx.xxx
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