| Primary Device ID | G079ITP0050 |
| NIH Device Record Key | b4d4e92e-029d-4419-ba8d-f76e653b8eb2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | InteliPowder |
| Version Model Number | ITP-005 |
| Company DUNS | 037368183 |
| Company Name | Intelivation, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | G079ITP0050 [Primary] |
| KGN | Wound Dressing With Animal-Derived Material(S) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-26 |
| Device Publish Date | 2025-08-18 |
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| G079C5080000230 - MIS Golden Isles Pedicle Screw System | 2026-02-09 K wire 500mm SS |
| G079C5080000250 - MIS Golden Isles Pedicle Screw System | 2026-02-09 T25 Short; Egg Handle |
| G079C5080000260 - MIS Golden Isles Pedicle Screw System | 2026-02-09 GI MIS Head Turner |