DEVICE: CeMend 10-48 mold insert press (08058964728906)

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Device Record History
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Device Identifier (DI) Information
CeMend 10-48 mold insert press
AR-902-04
In Commercial Distribution

G21 SRL
08058964728906
GS1

1
431529195 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
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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?
45105 Orthopaedic cement spacer mould
A moulding device designed to form an implantable provisional joint prosthesis component out of orthopaedic cement (otherwise known as a cement spacer), which is used in two-stage joint revision typically to treat joint arthroplasty infection. It is filled with prepared antibiotic-containing bone cement which cures into the shape of the prosthesis and is subsequently placed into the joint space until replaced with a revision joint prosthesis. It is typically made of silicone and available in a variety of shapes and sizes for different joint applications. This is a single-use device.
Active false
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FDA Product Code

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Product Code Product Code Name
MBB Bone Cement, Antibiotic
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K202338 000
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Sterilization
No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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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
No Device Sizes
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Device Record Status
ef7c2445-2d40-4eea-b504-80933f321ef2
March 26, 2025
1
March 18, 2025
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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
No Package DIs found
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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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