DEVICE: NA (07630031716705)
Device Identifier (DI) Information
NA
non-surgically Invasive Instruments
In Commercial Distribution
034.053V4
Institut Straumann AG
non-surgically Invasive Instruments
In Commercial Distribution
034.053V4
Institut Straumann AG
T-Sleeve, Ø 5 mm, height 5 mm, guided, stainless steel
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? |
---|---|---|---|---|
64371 | Dental implantation drilling template guide-sleeve |
A small tubular device intended to be inserted within the guide holes of a dental implantation drilling template (a device used to guide drilling in the jawbone during dental implant placement/fixation) to guide the implant into position. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NDP | Accessories, implant, dental, endosseous |
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 |
---|
Height: 5 Millimeter |
Outer Diameter: 5 Millimeter |
Device Record Status
d35dddb2-3548-4e44-99fc-fa259f02dd8b
April 21, 2023
2
December 02, 2022
April 21, 2023
2
December 02, 2022
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:
07630031757265
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)448-8168
info.usa@straumann.com
info.usa@straumann.com