DEVICE: PROMOS (07611996092097)
Device Identifier (DI) Information
PROMOS
75005288
In Commercial Distribution
75005288
Smith & Nephew, Inc.
75005288
In Commercial Distribution
75005288
Smith & Nephew, Inc.
PROMOS CASE 2 GLENOID STANDARD
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 |
---|---|
Instrument tray | A flat shallow vessel, usually with a raised rim, providing a suitable platform for containing many medical, usually surgical instruments and items. It is typically made of stainless steel and designed to fit into other devices, e.g., supply trolleys, storage systems or sterilizers. This device may or may not be fitted with a lid or cover. This is a reusable device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FSM | TRAY, SURGICAL, INSTRUMENT |
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 |
---|
No Device Sizes |
Device Record Status
f2f02843-9ca5-4b0b-ad00-516e0e51c5c3
March 29, 2018
2
November 25, 2015
March 29, 2018
2
November 25, 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(800)238-7538
GUDID@SMITH-NEPHEW.COM
GUDID@SMITH-NEPHEW.COM