| Primary Device ID | 10868643000491 | 
| NIH Device Record Key | d99dea2c-3b2b-46e9-bed4-e16944ef4a4b | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Hummingbird® Cranial Access Kit | 
| Version Model Number | IC40 | 
| Catalog Number | IC40 | 
| Company DUNS | 056999617 | 
| Company Name | IRRAS USA | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | true | 
| 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 | 
| Phone | 800-213-4604 | 
| info@irras.com | |
| Phone | 800-213-4604 | 
| info@irras.com | |
| Phone | 800-213-4604 | 
| info@irras.com | |
| Phone | 800-213-4604 | 
| info@irras.com | |
| Phone | 800-213-4604 | 
| info@irras.com | |
| Phone | 800-213-4604 | 
| info@irras.com | |
| Phone | 800-213-4604 | 
| info@irras.com | |
| Phone | 800-213-4604 | 
| info@irras.com | |
| Phone | 800-213-4604 | 
| info@irras.com | |
| Phone | 800-213-4604 | 
| info@irras.com | |
| Phone | 800-213-4604 | 
| info@irras.com | |
| Phone | 800-213-4604 | 
| info@irras.com | |
| Phone | 800-213-4604 | 
| info@irras.com | |
| Phone | 800-213-4604 | 
| info@irras.com | |
| Phone | 800-213-4604 | 
| info@irras.com | |
| Phone | 800-213-4604 | 
| info@irras.com | |
| Phone | 800-213-4604 | 
| info@irras.com | |
| Phone | 800-213-4604 | 
| info@irras.com | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00868643000494 [Primary] | 
| GS1 | 10868643000491 [Package] Contains: 00868643000494 Package: Box [1 Units] In Commercial Distribution | 
| Steralize Prior To Use | true | 
| Device Is Sterile | true | 
[10868643000491]
Ethylene Oxide
[10868643000491]
Ethylene Oxide
[10868643000491]
Ethylene Oxide
[10868643000491]
Ethylene Oxide
[10868643000491]
Ethylene Oxide
[10868643000491]
Ethylene Oxide
[10868643000491]
Ethylene Oxide
[10868643000491]
Ethylene Oxide
[10868643000491]
Ethylene Oxide
[10868643000491]
Ethylene Oxide
[10868643000491]
Ethylene Oxide
[10868643000491]
Ethylene Oxide
[10868643000491]
Ethylene Oxide
[10868643000491]
Ethylene Oxide
[10868643000491]
Ethylene Oxide
[10868643000491]
Ethylene Oxide
[10868643000491]
Ethylene Oxide
[10868643000491]
Ethylene Oxide
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2019-10-18 | 
| Device Publish Date | 2019-10-10 | 
| 10868643000484 | IC40-D Cranial Access Kit (w/ Drugs) | 
| 10850013266194 | IC42 Cranial Access Kit | 
| 10850013266187 | IC42-D Cranial Access Kit (w/ Drugs) | 
| 10868643000491 | IC40 Cranial Access Kit |