DEVICE: PROMOS (07611996087680)

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Device Identifier (DI) Information

PROMOS
75005252
75005252
Smith & Nephew, Inc.
07611996087680
GS1
1
PROMOS SLEEVE TO CUTTING DEVICE
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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
Surgical instrument sleeve, reusable A hand-held surgical tubular device designed to hold (grip) an implant (e.g., an orthopaedic bone screw) and/or facilitate the acceptance of an orthopaedic instrument through it (e.g., a screwdriver or a smaller diameter sleeve). Its function is to rigidly couple an implant to an instrument to guide and stabilize an instrument/implant, and/or to protect the surgeon's gloved hand and patient tissue, while the surgeon performs manipulations (e.g., rotates the screw for fixation with the surgical instrument) during an orthopaedic procedure. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
FZX Guide, surgical, instrument
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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 Status

In Commercial Distribution
November 25, 2015

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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)

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

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Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)238-7538
GUDID@SMITH-NEPHEW.COM
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