DEVICE: PROMOS (07611996039061)
Device Identifier (DI) Information
PROMOS
75006565
In Commercial Distribution
75006565
Smith & Nephew, Inc.
75006565
In Commercial Distribution
75006565
Smith & Nephew, Inc.
PROMOS GLENOID TEMPLATE FORCEPS
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 |
---|---|
Shoulder glenoid fossa prosthesis | A sterile implantable component of a total shoulder prosthesis (glenoid component) designed to replace or repair the glenoid fossa. It is cup-like in shape and typically made of polyethylene (PE), but may be made of metal or a combination of PE and metal; it may include fixation devices (e.g., screws) for attachment to the scapula. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HSD | PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
c26b4803-e218-4cef-8950-14d1925024d2
March 29, 2018
2
August 29, 2015
March 29, 2018
2
August 29, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(978)269-4663
ROBERT.GUZMAN@SMITH-NEPHEW.COM
ROBERT.GUZMAN@SMITH-NEPHEW.COM