| Primary Device ID | M9432001280040 | 
| NIH Device Record Key | 634a5854-a20d-46ae-891e-ffd12e2ec223 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Version Model Number | 20-0128-004 | 
| Company DUNS | 963359513 | 
| Company Name | Spinal Simplicity, 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 | 
| Device Issuing Agency | Device ID | 
|---|---|
| HIBCC | M9432001280040 [Primary] | 
| LXH | Orthopedic Manual Surgical Instrument | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[M9432001280040]
Moist Heat or Steam Sterilization
[M9432001280040]
Moist Heat or Steam Sterilization
[M9432001280040]
Moist Heat or Steam Sterilization
[M9432001280040]
Moist Heat or Steam Sterilization
[M9432001280040]
Moist Heat or Steam Sterilization
[M9432001280040]
Moist Heat or Steam Sterilization
[M9432001280040]
Moist Heat or Steam Sterilization
[M9432001280040]
Moist Heat or Steam Sterilization
[M9432001280040]
Moist Heat or Steam Sterilization
[M9432001280040]
Moist Heat or Steam Sterilization
[M9432001280040]
Moist Heat or Steam Sterilization
[M9432001280040]
Moist Heat or Steam Sterilization
[M9432001280040]
Moist Heat or Steam Sterilization
[M9432001280040]
Moist Heat or Steam Sterilization
[M9432001280040]
Moist Heat or Steam Sterilization
[M9432001280040]
Moist Heat or Steam Sterilization
[M9432001280040]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2024-08-05 | 
| Device Publish Date | 2024-07-26 | 
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