Wrap-Ease™ Cushions
GUDID 50732224003066
X-Ray cushions
CROSSTEX INTERNATIONAL, INC.
Dental x-ray film holder, single-use| Primary Device ID | 50732224003066 |
| NIH Device Record Key | 58490e74-1228-4379-9bd1-a059e917928e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Wrap-Ease™ Cushions |
| Version Model Number | BWWEL |
| Company DUNS | 057728685 |
| Company Name | CROSSTEX INTERNATIONAL, INC. |
| Device Count | 50 |
| 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 | 00732224003061 [Unit of Use] |
| GS1 | 10732224003068 [Primary] |
| GS1 | 50732224003066 [Package] Contains: 10732224003068 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 [Wrap-Ease™ Cushions]
| 50732224003073 | X-Ray cushions |
| 50732224003066 | X-Ray cushions |
Trademark Results [Wrap-Ease]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 WRAP-EASE 78645516 3093144 Dead/Cancelled |
CROSSTEX INTERNATIONAL, INC. 2005-06-07 |
 WRAP-EASE 74415085 not registered Dead/Abandoned |
Paper Manufacturers Company 1993-07-21 |
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