Primary Device ID | 00889795128140 |
NIH Device Record Key | 21c48bf9-c1c1-4e1b-bb9e-32892c23964a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Grappler R3FLEX Stabilization System |
Version Model Number | P82-001-1237-SK |
Catalog Number | P82-001-1237-SK |
Company DUNS | 042961576 |
Company Name | PARAGON 28, INC. |
Device Count | 1 |
DM Exempt | true |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
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 |
---|---|
GS1 | 00889795128140 [Primary] |
MBI | Fastener, fixation, nondegradable, soft tissue |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-07-16 |
Device Publish Date | 2024-07-08 |
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