RediFoam™ MTFA39B
GUDID 00841439110928
Two-part Foaming Agent Part A (12.8oz) and Foaming Agent Part R (15oz)
MEDTEC, INC.
Patient positioning foam mould kit Patient positioning foam mould kit Patient positioning foam mould kit Patient positioning foam mould kit Patient positioning foam mould kit Patient positioning foam mould kit Patient positioning foam mould kit Patient positioning foam mould kit Patient positioning foam mould kit Patient positioning foam mould kit Patient positioning foam mould kit Patient positioning foam mould kit Patient positioning foam mould kit Patient positioning foam mould kit Patient positioning foam mould kit Patient positioning foam mould kit Patient positioning foam mould kit Patient positioning foam mould kit Patient positioning foam mould kit Patient positioning foam mould kit Patient positioning foam mould kit Patient positioning foam mould kit Patient positioning foam mould kit Patient positioning foam mould kit Patient positioning foam mould kit Patient positioning foam mould kit Patient positioning foam mould kit Patient positioning foam mould kit Patient positioning foam mould kit Patient positioning foam mould kit Patient positioning foam mould kit Patient positioning foam mould kit Patient positioning foam mould kit| Primary Device ID | 00841439110928 |
| NIH Device Record Key | cde4c318-7907-4d34-8cd1-45a6d228f8fb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RediFoam™ |
| Version Model Number | MTFA39B |
| Catalog Number | MTFA39B |
| Company DUNS | 103977526 |
| Company Name | MEDTEC, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| 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 | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
Device Dimensions
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
| Length | 19.4 Centimeter |
| Width | 4.1 Centimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile. Flammable, keep away from fire or flame. Keep away from sunlight. |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841439110928 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K951808
FDA Product Code
| IYE | Accelerator, linear, medical |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-06-14 |
| Device Publish Date | 2017-08-02 |
On-Brand Devices [RediFoam™]
| 00841439110928 | Two-part Foaming Agent Part A (12.8oz) and Foaming Agent Part R (15oz) |
| 00841439110911 | Two-part Foaming Agent Part A (15.8oz) and Foaming Agent Part R (19.2oz) |
| 00841439110904 | Two-part Foaming Agent Part A (21.8oz) and Foaming Agent Part R (24.6oz) |
Trademark Results [RediFoam]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 REDIFOAM 87748673 not registered Live/Pending |
GOJO Industries, Inc. 2018-01-09 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.