Apollo Onyx 105-5095-000
GUDID 00836462002463
Delivery Micro Catheter
Micro Therapeutics, Inc.
Vascular guide-catheter, single-use| Primary Device ID | 00836462002463 |
| NIH Device Record Key | 64fb84fb-83d2-4152-93b5-d5f133125b6b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Apollo Onyx |
| Version Model Number | 105-5095-000 |
| Catalog Number | 105-5095-000 |
| Company DUNS | 826110710 |
| Company Name | Micro Therapeutics, 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 | 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 |
Customer Support Contacts
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Length | 165 Centimeter |
| Device Size Text, specify | 0 |
| Length | 165 Centimeter |
| Device Size Text, specify | 0 |
| Length | 165 Centimeter |
| Device Size Text, specify | 0 |
| Length | 165 Centimeter |
| Device Size Text, specify | 0 |
| Length | 165 Centimeter |
| Device Size Text, specify | 0 |
| Length | 165 Centimeter |
| Device Size Text, specify | 0 |
| Length | 165 Centimeter |
| Device Size Text, specify | 0 |
| Length | 165 Centimeter |
| Device Size Text, specify | 0 |
| Length | 165 Centimeter |
| Device Size Text, specify | 0 |
| Length | 165 Centimeter |
| Device Size Text, specify | 0 |
| Length | 165 Centimeter |
| Device Size Text, specify | 0 |
| Length | 165 Centimeter |
| Device Size Text, specify | 0 |
| Length | 165 Centimeter |
| Device Size Text, specify | 0 |
| Length | 165 Centimeter |
| Device Size Text, specify | 0 |
| Length | 165 Centimeter |
| Device Size Text, specify | 0 |
| Length | 165 Centimeter |
| Device Size Text, specify | 0 |
| Length | 165 Centimeter |
| Device Size Text, specify | 0 |
| Length | 165 Centimeter |
| Device Size Text, specify | 0 |
| Length | 165 Centimeter |
| Device Size Text, specify | 0 |
| Length | 165 Centimeter |
| Device Size Text, specify | 0 |
| Length | 165 Centimeter |
| Device Size Text, specify | 0 |
| Length | 165 Centimeter |
| Device Size Text, specify | 0 |
| Length | 165 Centimeter |
| Device Size Text, specify | 0 |
| Length | 165 Centimeter |
| Device Size Text, specify | 0 |
| Length | 165 Centimeter |
| Device Size Text, specify | 0 |
| Length | 165 Centimeter |
| Device Size Text, specify | 0 |
| Length | 165 Centimeter |
| Device Size Text, specify | 0 |
| Length | 165 Centimeter |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00836462002463 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P030004
FDA Product Code
| MFE | Agent, injectable, embolic |
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 | 2019-01-23 |
| Device Publish Date | 2015-06-08 |
On-Brand Devices [Apollo Onyx]
| 00836462002487 | Delivery Micro Catheter |
| 00836462002463 | Delivery Micro Catheter |
Trademark Results [Apollo Onyx]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 APOLLO ONYX 97128846 not registered Live/Pending |
Covidien LP 2021-11-17 |
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