DEVICE: Athena Surgical RMUS System (00860003619810)

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Device Record History
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Device Identifier (DI) Information
Athena Surgical RMUS System
9001-1
In Commercial Distribution

Athena Surgical LLC
00860003619810
GS1

1
117067792 *Terms of Use
Mid-Urethral Sling Assembly, Round Needles
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Device Characteristics
MR Safe
No
No
Yes
Yes
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?
47986 Female stress urinary incontinence surgical mesh-sling, synthetic polymer
A woven/knitted or porous strip of material made of non-bioabsorbable synthetic polymer (e.g., polypropylene) intended to be permanently implanted (via transobturator, transvaginal, retropubic or suprapubic approach) to support the urethra for the treatment of female stress urinary incontinence (SUI), resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). It typically includes an integral adjustment suture which may contain bioabsorbable polymer materials. It may also be referred to as a tape or subfascial hammock. Disposable devices associated with implantation may be supplied with the mesh-sling.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K210087 000
No CLOSE

Sterilization
Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Width: 1.1 Centimeter
Length: 45 Centimeter
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Device Record Status
73ffa0b1-0105-480c-9dd2-c0a965064d8a
June 10, 2022
2
July 30, 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
20860003619814 3 00860003619810 In Commercial Distribution
10860003619817 15 00860003619810 In Commercial Distribution
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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

[?]
No Customer Contact currently defined
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