DEVICE: A+Wedge® (00810038095691)
Device Identifier (DI) Information
A+Wedge®
GWAS01
In Commercial Distribution
GWAS01
GARRISON DENTAL SOLUTIONS, L.L.C.
GWAS01
In Commercial Distribution
GWAS01
GARRISON DENTAL SOLUTIONS, L.L.C.
Wedge Sample Kit: 50 Count
(25) X-Small Yellow, (25) Small Blue
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
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? |
---|---|---|---|---|
45007 | Dental wedge, single-use |
A small, dental device intended to be introduced between two adjacent teeth for slight separation during a dental procedure. It is typically used during the placement of a filling material, or to stabilize and support other devices (e.g., a matrix band and/or rubber dam). It may include a removable shield intended to protect the healthy tooth/teeth from damage by the instruments. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EJB | Handle, Instrument, Dental |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K140144 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
397c49d3-9954-41cf-a7a8-485dcf334555
February 05, 2024
2
April 24, 2020
February 05, 2024
2
April 24, 2020
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
[?]
888-437-0032
gds@garrisondental.com
gds@garrisondental.com