DEVICE: Deep Tissue Handpiece Disposable Shields (00647529002728)
Device Identifier (DI) Information
Deep Tissue Handpiece Disposable Shields
6400310
In Commercial Distribution
6400310
Biolase, Inc.
6400310
In Commercial Distribution
6400310
Biolase, Inc.
Disposable shields are single-use, non-sterile, clear plastic protective covers intended for and specifically designed for use with the Biolase Deep Tissue Handpiece during pain therapy procedures. The disposable shields must be discarded after one-time use to avoid cross-contamination between patients.
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? |
---|---|---|---|---|
61049 | Instrument/equipment drape, single-use, non-sterile |
A non-sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various instruments/equipment (e.g., dental chairs, treatment tables), to provide a barrier against cross-contamination in the home or healthcare facility. This is a single-use device.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MMP | Cover, Barrier, Protective |
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 |
---|
No Device Sizes |
Device Record Status
7e301b31-21cc-4220-9a57-03cad263d0bc
June 12, 2023
3
September 25, 2018
June 12, 2023
3
September 25, 2018
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:
00647529002698
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-321-6717
Diodeservice@biolase.com
Diodeservice@biolase.com