| Primary Device ID | M9935042040 | 
| NIH Device Record Key | 39bebee7-d46e-4092-8663-a5cdf6da0c44 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | GSO GS1 Spacer System | 
| Version Model Number | 504204 | 
| Company DUNS | 028008203 | 
| Company Name | GOLD STANDARD ORTHOPEDICS, 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 | true | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
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| Device Size Text, specify | 0 | 
| Device Issuing Agency | Device ID | 
|---|---|
| HIBCC | M9935042040 [Primary] | 
| LRP | Tray, Surgical | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
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[M9935042040]
Moist Heat or Steam Sterilization
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 3 | 
| Public Version Date | 2020-10-21 | 
| Device Publish Date | 2018-09-21 | 
| M9935042040 | Spacer Case | 
| M9935042440 | Bone Tap With 1/4" Square QC | 
| M9935042430 | Bone Tap With 1/4" Square QC |