Ultra-speed 8818890
GUDID 60889978818891
ULTRA-SPEED 150PKT 30.5X40.5 FILM DF58 L
CARESTREAM HEALTH, INC.
Dental x-ray film, non-screen| Primary Device ID | 60889978818891 |
| NIH Device Record Key | 27a4ee33-3bd1-4146-9298-f4e8666160bf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ultra-speed |
| Version Model Number | Ultra-speed |
| Catalog Number | 8818890 |
| Company DUNS | 793169512 |
| Company Name | CARESTREAM HEALTH, INC. |
| Device Count | 150 |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Handling Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889978818899 [Unit of Use] |
| GS1 | 40889978818897 [Primary] |
| GS1 | 60889978818891 [Package] Contains: 40889978818897 Package: Case [50 Units] In Commercial Distribution |
FDA Product Code
| IWZ | Film, radiographic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-04 |
| Device Publish Date | 2023-06-26 |
On-Brand Devices [Ultra-speed]
| 60889978987870 | Ultra-speed 100PKT 30.5x40.5 film DF57C |
| 60889978393046 | Ultra-speed 50PKT 30.5x40.5 film DF40 2B |
| 60889978348657 | Ultra-speed 50PKT 22x35 film DF48 0BW |
| 60889971753663 | Ultra-speed 130PKT 30.5x40.5 film DF57 |
| 60889971717139 | Ultra-speed 100PKT 30.5x40.5 film DF58C |
| 60889971666161 | Ultra-speed 25PKT 57x76 film DF50 |
| 60889971666123 | Ultra-speed 25PKT 57x76 film DF49 |
| 60889971658197 | Ultra-speed 150PKT 30.5x40.5 film DF58 |
| 60889971491756 | Ultra-speed 150PKT 30.5x40.5 film DF57 |
| 60889971491732 | Ultra-speed 150PKT 30.5x40.5 film DF58 |
| 60889971445360 | Ultra-speed 75PKT 22x35 film DF54C |
| 60889971296771 | Ultra-speed 100PKT 27x54 film DF42 3BW |
| 60889971273741 | Ultra-speed 100PKT 24x40 film DF56 |
| 60889971273727 | Ultra-speed 100PKT 24x40 film DF55 |
| 60889971228932 | Ultra-speed 100PKT 22x35 film DF53 |
| 60889971228840 | Ultra-speed 100PKT 22x35 film DF54 |
| 60889978818891 | ULTRA-SPEED 150PKT 30.5X40.5 FILM DF58 L |
Trademark Results [Ultra-speed]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ULTRA-SPEED 73541947 1403777 Live/Registered |
UNIVERSAL PACKAGING MACHINERY CORPORATION 1985-06-10 |
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