Primary Device ID | 18800016902799 |
NIH Device Record Key | 3a7904a0-b5dd-4b97-b449-e5aef07426f3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Coupling Gel |
Version Model Number | XG00-00010-001 |
Company DUNS | 689842183 |
Company Name | CLASSYS Inc. |
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 | true |
Device Combination Product | false |
Single Use | false |
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 | 08800016902792 [Primary] |
GS1 | 18800016902799 [Package] Contains: 08800016902792 Package: [4 Units] In Commercial Distribution |
GEI | Electrosurgical, Cutting & Coagulation & Accessories |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-08-12 |
Device Publish Date | 2024-08-03 |
08800016903140 - Max-25 | 2025-07-10 |
08800016903171 - Max-M25 | 2025-07-10 |
08800016903423 - Max-25C | 2025-07-10 |
08800016903447 - Max-64C | 2025-07-10 |
08800016903454 - Max-M25C | 2025-07-10 |
08800016904246 - MTR-AC-01 | 2025-07-10 |
08800016904253 - MTR-AC-04 | 2025-07-10 |
08800016904291 - MTR-AC-27G | 2025-07-10 |