OPSoft® Mouthguards for laser (sample)
GUDID 10697660004881
The OPSoft mouthguard is intended for protection during hair removal, cutaneous treatment, and perioral procedures with laser, IPL or RF.
Oculo-Plastik Inc
Laser protective mouthguard Laser protective mouthguard Laser protective mouthguard Laser protective mouthguard Laser protective mouthguard Laser protective mouthguard Laser protective mouthguard Laser protective mouthguard Laser protective mouthguard Laser protective mouthguard Laser protective mouthguard Laser protective mouthguard Laser protective mouthguard Laser protective mouthguard Laser protective mouthguard Laser protective mouthguard| Primary Device ID | 10697660004881 |
| NIH Device Record Key | e8cfce48-d32f-4c8e-9c93-b7de6df6a37f |
| Commercial Distribution Discontinuation | 2022-03-24 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | OPSoft® Mouthguards for laser (sample) |
| Version Model Number | 60-104SS |
| Company DUNS | 257382580 |
| Company Name | Oculo-Plastik Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 514-381-3292 |
| sales@oculoplastik.com | |
| Phone | 514-381-3292 |
| sales@oculoplastik.com | |
| Phone | 514-381-3292 |
| sales@oculoplastik.com | |
| Phone | 514-381-3292 |
| sales@oculoplastik.com | |
| Phone | 514-381-3292 |
| sales@oculoplastik.com | |
| Phone | 514-381-3292 |
| sales@oculoplastik.com | |
| Phone | 514-381-3292 |
| sales@oculoplastik.com | |
| Phone | 514-381-3292 |
| sales@oculoplastik.com | |
| Phone | 514-381-3292 |
| sales@oculoplastik.com | |
| Phone | 514-381-3292 |
| sales@oculoplastik.com | |
| Phone | 514-381-3292 |
| sales@oculoplastik.com | |
| Phone | 514-381-3292 |
| sales@oculoplastik.com | |
| Phone | 514-381-3292 |
| sales@oculoplastik.com | |
| Phone | 514-381-3292 |
| sales@oculoplastik.com | |
| Phone | 514-381-3292 |
| sales@oculoplastik.com | |
| Phone | 514-381-3292 |
| sales@oculoplastik.com |
Device Dimensions
| Width | 4.5 Centimeter |
| Length | 12 Centimeter |
| Width | 4.5 Centimeter |
| Length | 12 Centimeter |
| Width | 4.5 Centimeter |
| Length | 12 Centimeter |
| Width | 4.5 Centimeter |
| Length | 12 Centimeter |
| Width | 4.5 Centimeter |
| Length | 12 Centimeter |
| Width | 4.5 Centimeter |
| Length | 12 Centimeter |
| Width | 4.5 Centimeter |
| Length | 12 Centimeter |
| Width | 4.5 Centimeter |
| Length | 12 Centimeter |
| Width | 4.5 Centimeter |
| Length | 12 Centimeter |
| Width | 4.5 Centimeter |
| Length | 12 Centimeter |
| Width | 4.5 Centimeter |
| Length | 12 Centimeter |
| Width | 4.5 Centimeter |
| Length | 12 Centimeter |
| Width | 4.5 Centimeter |
| Length | 12 Centimeter |
| Width | 4.5 Centimeter |
| Length | 12 Centimeter |
| Width | 4.5 Centimeter |
| Length | 12 Centimeter |
| Width | 4.5 Centimeter |
| Length | 12 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10697660004881 [Primary] |
FDA Product Code
| BRW | Protector, Dental |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2022-03-25 |
| Device Publish Date | 2019-11-25 |
Devices Manufactured by Oculo-Plastik Inc
| 10697660001903 - Sutcliffe SS Shield & Retractor for the Laser (flat) (non glare), refurb . | 2022-03-25 The SUTCLIFFE shields, with all surfaces nonreflective for safe use with the laser, come in many configurations for various appl |
| 10697660001927 - Sutcliffe SS Shield & Retractor for the Laser (bent) (non glare), refurb. | 2022-03-25 The SUTCLIFFE shields, with all surfaces nonreflective for safe use with the laser, come in many configurations for various appl |
| 10697660001965 - Sutcliffe Boey SS Laser Shield with all holes in one (non glare), refurb. | 2022-03-25 The Sutcliffe Boey is an instrument to treat cutaneous lesions (freckles, etc) during laser procedures. The holes limit the size |
| 10697660001989 - Laser SWAB SS Tissue Handler And Backstop for Laser (non glare) | 2022-03-25 The Laser Swab is an instrument used in blepharoplasty at superior and inferior levels. It is used to grip and roll adipose (fat |
| 10697660001996 - Laser SWAB SS Tissue Handler And Backstop for Laser (non glare), refurb. | 2022-03-25 The Laser Swab is an instrument used in blepharoplasty at superior and inferior levels. It is used to grip and roll adipose (fat |
| 10697660002023 - Khan-Jaeger SS Lid Plate for the Laser (non glare), refurb. | 2022-03-25 The Khan-Jaeger is a curved instrument partially non-glare for blepharoplasty. The usage of this instrument is to block laser be |
| 10697660002047 - Jaeger SS Lid Plate for the Laser (non glare), refurb. | 2022-03-25 The Khan-Jaeger is a curved instrument partially non-glare for blepharoplasty. The usage of this instrument is to block laser be |
| 10697660003297 - Plastic Jaeger lid plates, t-yellow more concave model with small & medium ends | 2022-03-25 Plastic Jaeger lid plates, t-yellow more concave model with small & medium ends |
Trademark Results [OPSoft]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OPSOFT 78169153 2736893 Live/Registered |
OCULO-PLASTIK, INC. 2002-09-30 |
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