Spetzler™ Lighted Suction Tube, 7 French, 120mm long
GUDID 10817489025267
Spetzler™ Lighted Suction Tube, 7 French, 120mm long
KATALYST SURGICAL LLC
Surgical/emergency suction cannula, illuminating, single-use| Primary Device ID | 10817489025267 |
| NIH Device Record Key | 70344434-4358-41f5-9b72-34307ac26933 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spetzler™ Lighted Suction Tube, 7 French, 120mm long |
| Version Model Number | DN1507-120 |
| Company DUNS | 007883297 |
| Company Name | KATALYST SURGICAL LLC |
| Device Count | 5 |
| 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 | true |
| 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 |
|---|---|
| GS1 | 00817489025260 [Unit of Use] |
| GS1 | 10817489025267 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K141781
FDA Product Code
| FST | Light, Surgical, Fiberoptic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-04-20 |
| Device Publish Date | 2017-08-09 |
Devices Manufactured by KATALYST SURGICAL LLC
Trademark Results [Spetzler]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPETZLER 77726480 not registered Dead/Abandoned |
Spetzler, Robert F. 2009-04-30 |
 SPETZLER 75563950 not registered Dead/Abandoned |
Robert F. Spetzler, M.D. 1998-10-02 |
 SPETZLER 73408581 1350488 Dead/Cancelled |
AMERICAN HOSPITAL SUPPLY CORPORATION 1983-01-07 |
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