| Primary Device ID | 00815948022416 |
| NIH Device Record Key | 697a1ab4-eec8-4d7f-a51f-ee7599ef8cd4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | REAL System Bands |
| Version Model Number | BND-A |
| Company DUNS | 191077671 |
| Company Name | PENUMBRA, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
|---|---|
| GS1 | 00815948022416 [Primary] |
| ISD | Exerciser, Measuring |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2021-06-08 |
| Device Publish Date | 2020-06-17 |
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| 00810169722237 - Indigo System | 2026-03-18 CAT16 HTORQ 100cm, SEL+ 120cm H1, LINK |
| 00810169722244 - Indigo System | 2026-03-18 CAT16 HTORQ 80cm, SEL+ 100cm H1, LINK |
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| 00810169722046 - swiftMATCH Coil, Extra Soft | 2026-02-03 swiftMATCH Coil, Extra Soft, 1mm x 2cm |
| 00810169722053 - swiftMATCH Coil, Extra Soft | 2026-02-03 swiftMATCH Coil, Extra Soft, 1mm x 3cm |
| 00810169722060 - swiftMATCH Coil, Extra Soft | 2026-02-03 swiftMATCH Coil, Extra Soft, 1mm x 5cm |