Laser kit

GUDID 30697660002256

Ocular Laser Shields (1 Regular Durette® II and 2 Medium Cox® II) (non glare) + spare headband & a case with 2 suction cups

Oculo-Plastik Inc

Corneal shield applicator
Primary Device ID30697660002256
NIH Device Record Key7c449f12-e7c2-4bef-887e-56f34ec68717
Commercial Distribution StatusIn Commercial Distribution
Brand NameLaser kit
Version Model Number21-330
Company DUNS257382580
Company NameOculo-Plastik Inc
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Producttrue
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone514-381-3292
Emailsales@oculoplastik.com

Device Identifiers

Device Issuing AgencyDevice ID
GS130697660002256 [Primary]

FDA Product Code

KYEInserter/Remover Contact Lens

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[30697660002256]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-15
Device Publish Date2019-11-07

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 ends2022-03-25 Plastic Jaeger lid plates, t-yellow more concave model with small & medium ends

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.