MicroMyst 205000DS
GUDID 30381780000116
MicroMyst Applicator (14cm) 5 pack - for use with Flow Regulator
Integra Lifesciences Corporation
Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel| Primary Device ID | 30381780000116 |
| NIH Device Record Key | 2a94b651-1382-4d8b-9f87-8008ed26d8e8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MicroMyst |
| Version Model Number | 205000DS |
| Catalog Number | 205000DS |
| Company DUNS | 083171244 |
| Company Name | Integra Lifesciences Corporation |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
| Length | 14 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780000112 [Primary] |
| GS1 | 30381780000116 [Package] Contains: 10381780000112 Package: BOX [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K082454
FDA Product Code
| FMF | Syringe, Piston |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-09-22 |
| Device Publish Date | 2016-12-29 |
Devices Manufactured by Integra Lifesciences Corporation
| 10381780537434 - Hermetic Plus™ | 2024-07-08 Hermetic™ Plus External CSF Drainage System with Anti-Reflux Valve and Needleless Injection Sites |
| 10381780537502 - Integra® | 2024-07-08 Integra® External Drainage System |
| 10381780537519 - Integra® | 2024-07-08 Integra® External Drainage System |
| 10381780537526 - Hermetic™ | 2024-07-08 Hermetic™ External CSF Drainage System with Pressure Tubing |
| 10381780252979 - Budde® | 2024-07-08 Budde® 1/4" X 4" Curved |
| 10381780537540 - Budde® | 2024-07-08 Budde® 3/8" X 4" Curved |
| 10381780537557 - Budde® | 2024-07-08 Budde® 5/8" X 4" Curved |
| 10381780537564 - Budde® | 2024-07-08 Budde® 3/4" X 4" Curved |
Trademark Results [MicroMyst]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MICROMYST 78563900 3178173 Live/Registered |
Confluent Surgical, Inc. 2005-02-09 |
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