DEVICE: Simplex (07613327128451)

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Device Record History
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Device Identifier (DI) Information
Simplex
6192-1-001
In Commercial Distribution
6192-1-001
Howmedica Osteonics Corp.
07613327128451
GS1

1
058311945 *Terms of Use
SpeedSet Full Dose Antibiotic Bone Cement, 10 pack catalog number is 6192-1-010
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Device Characteristics
Labeling does not contain MRI Safety Information
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?
46059 Orthopaedic cement, antimicrobial
A substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic prosthetic implants to the living bone and/or to fill voids in the case of bone pathologies, and to treat infected joint prostheses or osteomyelitis; it may also be used prophylactically in primary or uninfected revision total joint arthroplasty. It is typically made from methylmethacrylate, polymethylmethacrylate (PMMA), esters of methacrylic acid or copolymers containing polymethylmethacrylate and polystyrene, and contains an antimicrobial agent. After application, this device cannot be reused.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
LOD BONE CEMENT
MBB BONE CEMENT, ANTIBIOTIC
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K053198 000
K063857 000
No CLOSE

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

[?]
Storage and Handling
Handling Environment Temperature: between 6 and 23 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Weight: 40.0 Gram
Total Volume: 20.0 Milliliter
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Device Record Status
5eff8bdf-b625-445c-9a7e-8970c84f911d
June 19, 2020
4
June 19, 2017
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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
37613327128452 10 07613327128451 In Commercial Distribution pack
57613327128456 2 37613327128452 In Commercial Distribution case
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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
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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