Primary Device ID | B3901161701 |
NIH Device Record Key | 2bc65a6a-83c3-4a0e-81b5-175e2cc02b13 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Reprocessed Mako Blade Standard, 2mm |
Version Model Number | 116170 |
Company DUNS | 785616934 |
Company Name | SURETEK MEDICAL |
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 | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B3901161701 [Primary] |
GFA | Blade, Saw, General & Plastic Surgery, Surgical |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-09-26 |
Device Publish Date | 2025-09-18 |
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