DEVICE: Accu-Beam (B177FOR97020)
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Device Identifier (DI) Information
Accu-Beam
FOR-9702
Not in Commercial Distribution
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
FOR-9702
Not in Commercial Distribution
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
Kit of 13 Weighted Fiber Handpieces. Included UDIs are:
+B17710597800
+B17710597810
+B17710597820
+B17710597830
+B17710597840
+B17710597850
+B17710597860
+B17710597870
+B17710597880
+B17710597890
+B17710597900
+B17710597920
+B17710597930
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| No | |
| No | |
| Yes | |
| 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? |
|---|---|---|---|---|
| 61474 | General/multiple surgical laser system beam guide, reusable |
A surgical device intended to be connected to a general/multiple surgical laser system to invasively direct and deliver laser energy for multiple different surgical applications (non-dedicated), which may include vaporization, ablation, coagulation, haemostasis, excision, resection, incision of soft and cartilaginous tissue, and/or fragmentation of urinary and biliary calculi. It is typically a probe-, handpiece-, or tip-like device which includes fibreoptic materials; a fibreoptic cable may be included with the device. This is a reusable device.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| GEX | Powered Laser Surgical Instrument |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K952006 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
67ea08cb-7eaa-4049-97dd-2261751385df
June 02, 2023
4
May 07, 2020
June 02, 2023
4
May 07, 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
[?]
No Customer Contact currently defined