| Primary Device ID | G2231428300 | 
| NIH Device Record Key | 19f23cf6-5e14-410d-a5e2-754177c608ba | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Femtosecond Spatula | 
| Version Model Number | 14-2830 | 
| Company DUNS | 876570990 | 
| Company Name | Medetz Surgical Instruments LLC | 
| 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 | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Phone | 8004205135 | 
| emichaels@medetzsurgical.com | |
| Phone | 8004205135 | 
| emichaels@medetzsurgical.com | |
| Phone | 8004205135 | 
| emichaels@medetzsurgical.com | |
| Phone | 8004205135 | 
| emichaels@medetzsurgical.com | |
| Phone | 8004205135 | 
| emichaels@medetzsurgical.com | |
| Phone | 8004205135 | 
| emichaels@medetzsurgical.com | |
| Phone | 8004205135 | 
| emichaels@medetzsurgical.com | |
| Phone | 8004205135 | 
| emichaels@medetzsurgical.com | |
| Phone | 8004205135 | 
| emichaels@medetzsurgical.com | |
| Phone | 8004205135 | 
| emichaels@medetzsurgical.com | |
| Phone | 8004205135 | 
| emichaels@medetzsurgical.com | |
| Phone | 8004205135 | 
| emichaels@medetzsurgical.com | |
| Phone | 8004205135 | 
| emichaels@medetzsurgical.com | |
| Phone | 8004205135 | 
| emichaels@medetzsurgical.com | |
| Phone | 8004205135 | 
| emichaels@medetzsurgical.com | |
| Phone | 8004205135 | 
| emichaels@medetzsurgical.com | |
| Phone | 8004205135 | 
| emichaels@medetzsurgical.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| HIBCC | G2231428300 [Primary] | 
| HND | Spatula, Ophthalmic | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[G2231428300]
Moist Heat or Steam Sterilization
[G2231428300]
Moist Heat or Steam Sterilization
[G2231428300]
Moist Heat or Steam Sterilization
[G2231428300]
Moist Heat or Steam Sterilization
[G2231428300]
Moist Heat or Steam Sterilization
[G2231428300]
Moist Heat or Steam Sterilization
[G2231428300]
Moist Heat or Steam Sterilization
[G2231428300]
Moist Heat or Steam Sterilization
[G2231428300]
Moist Heat or Steam Sterilization
[G2231428300]
Moist Heat or Steam Sterilization
[G2231428300]
Moist Heat or Steam Sterilization
[G2231428300]
Moist Heat or Steam Sterilization
[G2231428300]
Moist Heat or Steam Sterilization
[G2231428300]
Moist Heat or Steam Sterilization
[G2231428300]
Moist Heat or Steam Sterilization
[G2231428300]
Moist Heat or Steam Sterilization
[G2231428300]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2024-09-24 | 
| Device Publish Date | 2024-09-16 | 
| G22312213390 | Femtosecond Spatula, 1.0mm Flattened, Spear-Shaped Tip, Round Knurled Handle, Stainless Steel | 
| G2231428300 | Machat LASIK Retreatment Spatula DBL-Ended, Cylindrical Spatula with Slightly Pointed tip, Angle |