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
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| M248437A2224SRL1 - MAYFIELD® | 2024-04-05 MAYFIELD® XR2 Extension Arm Assembly |
| M2483138R1 - Omni-Tract® | 2024-04-05 Deaver Fixed Retractor, 2.75in x 4.5in (7.0cm x 11.4cm) |
| M2483086P1 - Omni-Tract® | 2024-04-05 Arm, Fixed Angle, 8in x 12in (20.3cm x 30.5cm) x 75° |
| M2483145P1 - Omni-Tract® | 2024-04-05 Kelly Mod Retractor, 3in x 3in (7.6cm x 7.6cm) Fixed |
| M2483223P1 - Omni-Tract® | 2024-04-05 Fence Swivel Blade with 3/8in (1.0cm) Hole, 4in x 5in (10.2cm x 12.7cm) |
| M268S438A1200B1 - BUDDE® | 2024-04-05 SAMY™ Vascular Retractor Blade – Long 4.6" |
| M268S443A1012A1 - BUDDE® | 2024-04-05 BUDDE® Halo 12 inch (300 mm) Flex Arm |
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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