| Primary Device ID | G22315290590 |
| NIH Device Record Key | 06f41482-9822-4bb3-b306-95f991ad6e47 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Scalpel Handle |
| Version Model Number | 15-29059 |
| 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 | G22315290590 [Primary] |
| GDZ | Handle, Scalpel |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[G22315290590]
Moist Heat or Steam Sterilization
[G22315290590]
Moist Heat or Steam Sterilization
[G22315290590]
Moist Heat or Steam Sterilization
[G22315290590]
Moist Heat or Steam Sterilization
[G22315290590]
Moist Heat or Steam Sterilization
[G22315290590]
Moist Heat or Steam Sterilization
[G22315290590]
Moist Heat or Steam Sterilization
[G22315290590]
Moist Heat or Steam Sterilization
[G22315290590]
Moist Heat or Steam Sterilization
[G22315290590]
Moist Heat or Steam Sterilization
[G22315290590]
Moist Heat or Steam Sterilization
[G22315290590]
Moist Heat or Steam Sterilization
[G22315290590]
Moist Heat or Steam Sterilization
[G22315290590]
Moist Heat or Steam Sterilization
[G22315290590]
Moist Heat or Steam Sterilization
[G22315290590]
Moist Heat or Steam Sterilization
[G22315290590]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-28 |
| Device Publish Date | 2023-11-20 |
| G2231103340 | # 9 knife handle, 5", holds blades 10, 11, 12 & 15 |
| G22315290590 | Castro Needle Holder Curved, w/lock TL 11mm, OL 145mm(5 3/4") |