DEVICE: PROMOS (07611996111194)

Device Identifier (DI) Information

PROMOS
75018922
In Commercial Distribution
75018922
Smith & Nephew, Inc.
07611996111194
GS1

1
109903521 *Terms of Use
PROMOS REV TRIAL GLENOSPHERE CENTRIC DIA36
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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
Reverse shoulder head trial prosthesis A copy of a final reverse shoulder prosthesis head designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient and to ensure its proper orientation and positioning. It is hemisphere-shaped (glenosphere) and typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.
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FDA Product Code

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Product Code Product Code Name
LXH ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

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

7eb7d422-a2a7-43eb-8a0e-65b43613e9e1
March 29, 2018
2
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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

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