FDA.reportPublic FDA data

Deep Tissue Handpiece Disposable Shields

Primary DI
00647529002728
Brand
Deep Tissue Handpiece Disposable Shields
Company
Biolase, Inc.
Model
6400310
Catalog number
6400310
Device description
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.
Published
2018-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MMPCover, Barrier, Protective

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMPCover, Barrier, ProtectiveGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00647529002728PrimaryGS10
00647529002698Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00647529002728006475290027286475290027280647529002728
00647529002698006475290026986475290026980647529002698

GMDN Terms#

Term, Definition table
TermDefinition
Instrument/equipment drape, single-use, non-sterileA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-321-6717Diodeservice@biolase.com

Regulatory Flags#

DUNS number
152165700
Device count
20
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00647529004081EdgeProTip Assembly - Two-17mm, WL JUNO6200181,7230011,72300302023-06-19
00647529004098EdgeProTip Assembly - Three-10mm, WL JUNO6200152,7230008,72300132023-06-19
00647529004104EdgeProTip Assembly - One-21 mm, WL JUNO6200153,7230009,72300212023-06-19
00647529004111EdgeProTip Assembly - One-25 mm, WL JUNO6200154,7230010,72300222023-06-19
00647529004265Waterlase Laser TipsTip, MZ6-17mm6200824,72300142023-06-12
00647529003787Waterlase iPlus Dental Laser SystemLaserFresh Accessory Kit Bundle72200052023-08-01
00647529004296EdgeProTip Assembly - One-17 mm62001552023-06-19
00647529003763Waterlase Laser TipsRFT2-176201042,7230007,72300182023-06-12
00647529003800Waterlase Express Waterlase Express Tip Starter Kit, 37pk72300012023-06-12
00647529000670Waterlase Laser Tips MT4-66200301,72003032016-09-16
00647529001127Waterlase Laser Tips Z2-206000772,70001622016-09-16
00647529001158Waterlase Laser Tips Z2-286000774,70001652016-09-16
00647529001189Waterlase Laser Tips Z3-146000781,70001712016-09-16
00647529001196Waterlase Laser Tips Z3-186000782,70001722016-09-16
00647529001202Waterlase Laser Tips Z3-206000783,70001732016-09-16

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