DEVICE: Lamaze (B268L276190)
Device Identifier (DI) Information
Lamaze
L27619
In Commercial Distribution
L27619
TOMY INTERNATIONAL, INC.
L27619
In Commercial Distribution
L27619
TOMY INTERNATIONAL, INC.
Water Filled Chill Teethers
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
44272 | Teething device, fluid-filled |
A circular or cylindrical device filled with fluid (e.g., water) intended to be bitten by a patient (infant or adult) to soothe gums during the teething process. This is a reusable device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KKO | Ring, Teething, Fluid-Filled |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
7c3fc839-46d7-4cf6-a244-cc0f680efc75
September 13, 2019
3
July 01, 2018
September 13, 2019
3
July 01, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
B268L276198 | 4 | B268L276192 | In Commercial Distribution | Master | |
B268L276192 | 2 | B268L276190 | In Commercial Distribution | Retail | |
B268L276199 | 3 | B268L276198 | In Commercial Distribution | Master |
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
[?]
No Customer Contact currently defined