Edge-Ease™ Cushions
GUDID 50732224002960
X-Ray cushions, Blue
CROSSTEX INTERNATIONAL, INC.
Dental x-ray film holder, single-use| Primary Device ID | 50732224002960 |
| NIH Device Record Key | 45c1c7cb-756a-4286-aa69-07e59cd7a1f6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Edge-Ease™ Cushions |
| Version Model Number | BWEEB |
| Company DUNS | 057728685 |
| Company Name | CROSSTEX INTERNATIONAL, INC. |
| Device Count | 300 |
| 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 | 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 | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00732224002965 [Unit of Use] |
| GS1 | 10732224002962 [Primary] |
| GS1 | 50732224002960 [Package] Contains: 10732224002962 Package: [12 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K852170
FDA Product Code
| EGZ | Holder, film, x-ray |
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 | 2022-10-07 |
| Device Publish Date | 2022-09-29 |
On-Brand Devices [Edge-Ease™ Cushions]
| 50732224002977 | X-Ray cushions, White |
| 50732224002960 | X-Ray cushions, Blue |
Trademark Results [Edge-Ease]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EDGE-EASE 73566551 1399298 Live/Registered |
GRAINGER, VONDA STRONG 1985-11-04 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.