Advantage I-125® RSLN
GUDID M936IRLS20
Radioactive Seed Localization with I-125 seed, spacer, strand. 20 cm Needle
ISOAID, L.L.C.
Manual brachytherapy source, temporary placement| Primary Device ID | M936IRLS20 |
| NIH Device Record Key | fa67a692-fa43-4bdb-acc3-b4ee77a9fa13 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Advantage I-125® |
| Version Model Number | RSLN-20 |
| Catalog Number | RSLN |
| Company DUNS | 002751241 |
| Company Name | ISOAID, L.L.C. |
| Device Count | 9 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M936IRLS20 [Unit of Use] |
| HIBCC | M936IRLS20S9 [Primary] |
| HIBCC | M936IRLS20SS9 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K141701
FDA Product Code
| KXK | Source, Brachytherapy, Radionuclide |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[M936IRLS20]
Ethylene Oxide
[M936IRLS20]
Ethylene Oxide
[M936IRLS20]
Ethylene Oxide
[M936IRLS20]
Ethylene Oxide
[M936IRLS20]
Ethylene Oxide
[M936IRLS20]
Ethylene Oxide
[M936IRLS20]
Ethylene Oxide
[M936IRLS20]
Ethylene Oxide
[M936IRLS20]
Ethylene Oxide
[M936IRLS20]
Ethylene Oxide
[M936IRLS20]
Ethylene Oxide
[M936IRLS20]
Ethylene Oxide
[M936IRLS20]
Ethylene Oxide
[M936IRLS20]
Ethylene Oxide
[M936IRLS20]
Ethylene Oxide
[M936IRLS20]
Ethylene Oxide
[M936IRLS20]
Ethylene Oxide
[M936IRLS20]
Ethylene Oxide
[M936IRLS20]
Ethylene Oxide
[M936IRLS20]
Ethylene Oxide
[M936IRLS20]
Ethylene Oxide
[M936IRLS20]
Ethylene Oxide
[M936IRLS20]
Ethylene Oxide
[M936IRLS20]
Ethylene Oxide
[M936IRLS20]
Ethylene Oxide
[M936IRLS20]
Ethylene Oxide
[M936IRLS20]
Ethylene Oxide
[M936IRLS20]
Ethylene Oxide
[M936IRLS20]
Ethylene Oxide
[M936IRLS20]
Ethylene Oxide
[M936IRLS20]
Ethylene Oxide
[M936IRLS20]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-15 |
| Device Publish Date | 2022-02-07 |
On-Brand Devices [Advantage I-125®]
| M936IRLS20SSS0 | Radioactive Seed Localization with I-125 seed, spacer, strand. 20 cm Needle |
| M936IRLS20 | Radioactive Seed Localization with I-125 seed, spacer, strand. 20 cm Needle |
| M936IRLS20SS0 | Radioactive Seed Localization with I-125 seed, spacer, strand. 20 cm Needle |
| M936IRLS20S0 | Radioactive Seed Localization with I-125 seed, spacer, strand. 20 cm Needle |
| M936IBKSSAL9 | Secure Strand and Advantage Load with I-125 radioactive seeds. |
Trademark Results [Advantage I-125]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ADVANTAGE I-125 76142531 2560328 Live/Registered |
IsoAid 2000-10-10 |
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