DEVICE: Advanced Endodontic System (00850309007183)
Device Identifier (DI) Information
Advanced Endodontic System
90-2125E
In Commercial Distribution
90-2125E
ASI MEDICAL, INC.
90-2125E
In Commercial Distribution
90-2125E
ASI MEDICAL, INC.
Advanced Endodontic System
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| No | |
| No | |
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| 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? |
|---|---|---|---|---|
| 60390 | Laparoscopic wound closure thread |
A sterile, bioabsorbable, implantable, device intended to be used exclusively during laparoscopic surgery to approximate subcutaneous tissue after removal of the laparoscopic sleeve/port. It consists of a suture with an attached short tag (anchor), and often includes a plastic guide which can take different forms depending on the method of laparoscopic entry, and a metal (e.g., stainless steel) and/or plastic pusher. The guide and pusher are used to deliver the suture so that the tag is deep to the wound, with the suture trailing so that it can be ligated on removal of the laparoscopic sleeve/port.
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Active | true |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| LQY | Locator, Root Apex |
| EKX | Handpiece, Direct Drive, Ac-Powered |
| EKR | Plugger, Root Canal, Endodontic |
| EFA | Handpiece, Belt And/Or Gear Driven, Dental |
| EBZ | Activator, Ultraviolet, For Polymerization |
| DZI | Drill, Bone, Powered |
| EIA | Unit, Operative Dental |
| ELC | Scaler, Ultrasonic |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K123139 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Temperature: between -40 and 70 Degrees Celsius |
| Storage Environment Humidity: between 0 and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature: between 10 and 40 Degrees Celsius |
| Handling Environment Humidity: between 0 and 80 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
c082e56e-9373-4eb9-8c69-c386c6162884
July 06, 2018
3
October 31, 2016
July 06, 2018
3
October 31, 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
[?]
No Customer Contact currently defined