Fluoro-Shield 0011731M
GUDID 00857164008010
Radiation Reduction Gloves, Size 7 1/2
MUNDY MEDICAL MARKETING INC
Radiation shielding glove| Primary Device ID | 00857164008010 |
| NIH Device Record Key | 348651a0-9413-4c8b-a69b-a0e19d693669 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fluoro-Shield |
| Version Model Number | 011731M |
| Catalog Number | 0011731M |
| Company DUNS | 097037857 |
| Company Name | MUNDY MEDICAL MARKETING INC |
| Device Count | 1 |
| DM Exempt | false |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857164008010 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K893093
FDA Product Code
| LZC | Patient Examination Glove, Specialty |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-07-13 |
| Device Publish Date | 2018-06-12 |
On-Brand Devices [Fluoro-Shield]
| 00857164008041 | Radiation Reduction Gloves, Size 9 |
| 00857164008034 | Radiation Reduction Gloves, Size 8 1/2 |
| 00857164008027 | Radiation Reduction Gloves, Size 8 |
| 00857164008010 | Radiation Reduction Gloves, Size 7 1/2 |
| 00857164008003 | Radiation Reduction Gloves, Size 7 |
Trademark Results [Fluoro-Shield]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FLUORO-SHIELD 78517487 3095113 Live/Registered |
Aberdeen Road Company 2004-11-16 |
 FLUORO-SHIELD 76442070 not registered Dead/Abandoned |
Meridian Manufacturing Corp. 2002-08-15 |
 FLUORO-SHIELD 76235289 not registered Dead/Abandoned |
UV Technology Ltd. 2001-04-04 |
 FLUORO-SHIELD 74046641 1630735 Dead/Cancelled |
Acufex Microsurgical, Inc. 1990-04-06 |
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