DEVICE: NA (07332747092646)
Device Identifier (DI) Information
NA
38059
In Commercial Distribution
38059
Nobel Biocare AB
38059
In Commercial Distribution
38059
Nobel Biocare AB
Guided Tissue Punch NP-sleeve (3.75)
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 |
---|---|
Gingival punch, reusable | A dental instrument used to remove with precision a circular area of gum tissue during dental surgery, to allow access to a site for drilling and dental implant placement without the use of a scalpel. It will typically be designed with a handle at the proximal end or for mounting into a dental drill, and have a cylindrical hollow tube-like head with a sharp cutting edge at the distal end. It is typically made of high-grade stainless steel. This is a reusable device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DZI | DRILL, BONE, POWERED |
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 |
---|
Outer Diameter: 3.750 Millimeter |
Device Record Status
72fd47cb-0566-4fc1-9369-2989f1f2174f
March 29, 2018
2
September 17, 2016
March 29, 2018
2
September 17, 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
[?]
+1(800)322-5001
us.customerservice@nobelbiocare.com
us.customerservice@nobelbiocare.com