DEVICE: SURG. KIT FOR PREMIUM-SHELTA (D7701241263)
Device Identifier (DI) Information
SURG. KIT FOR PREMIUM-SHELTA
ZPRESH-INT
In Commercial Distribution
ZPRESH-INT
SWEDEN & MARTINA SPA
ZPRESH-INT
In Commercial Distribution
ZPRESH-INT
SWEDEN & MARTINA SPA
SURG. KIT FOR PREMIUM-SHELTA IMPLANT SYSTEM
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? |
---|---|---|---|---|
45147 | Dental/maxillofacial surgical procedure kit, non-medicated, reusable |
A collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K222640 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
fdcc88eb-9ba1-4d4d-8e54-68f543a1cf95
June 07, 2023
3
August 23, 2016
June 07, 2023
3
August 23, 2016
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
[?]
844.862.7846
info.us@sweden-martina.com
info.us@sweden-martina.com