Hysolate
GUDID 17630392901199
Flexi Dam Purple medium Adult (6x6), 30 pcs
Dent4You AG
Rubber dam, non-latex| Primary Device ID | 17630392901199 |
| NIH Device Record Key | dabafc6b-6ff0-45aa-91f2-9b2036c0c71a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hysolate |
| Version Model Number | H09945 |
| Company DUNS | 480152811 |
| Company Name | Dent4You AG |
| Device Count | 30 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Handling Environment Temperature | Between 0 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 26 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07630392901192 [Primary] |
| GS1 | 17630392901199 [Unit of Use] |
FDA Product Code
| EIE | Dam, Rubber |
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 | 2023-03-08 |
| Device Publish Date | 2023-02-28 |
On-Brand Devices [Hysolate]
| 17630392900376 | Latex DD Green medium adult (6x6), 2pcs |
| 17630392900369 | Latex DD Black pre-printed thin Adult (6x6), 2pcs |
| 17630392900352 | Latex DD Fiesta medium Adult (6x6), 360 pcs |
| 17630392900345 | Latex DD Fiesta medium Child (5x5), 364 pcs |
| 17630392900338 | Latex DD Blue heavy Adult (6x6), 36 pcs |
| 17630392900321 | Latex DD Fiesta heavy Adult (6x6), 36 pcs |
| 17630392900314 | Latex DD Fiesta heavy Child (5x5), 52 pcs |
| 17630392900307 | Latex DD Fiesta medium Adult (6x6), 36 pcs |
| 17630392900291 | Latex DD Fiesta medium Child (5x5), 52 pcs |
| 17630392900284 | Latex DD Fiesta thin Child (5x5), 52 pcs |
| 17630392900277 | Latex DD Fiesta thin Adult (6x6), 36 pcs |
| 17630392900260 | Latex DD Green medium Adult (6x6), 360 pcs |
| 17630392900253 | Latex DD Light medium Adult (6x6), 360 pcs |
| 17630392900246 | Latex DD Light medium Child (5x5), 364 pcs |
| 17630392900239 | Latex DD Light medium Child (5x5), 364 pcs |
| 17630392900222 | Latex DD Blue medium Adult (6x6), 36 pcs |
| 17630392900215 | Latex DD Blue medium Child (5x5), 52 pcs |
| 17630392900208 | Latex DD Green x-heavy Adult (6x6), 52 pcs |
| 17630392900192 | Latex DD Green heavy Adult (6x6), 52 pcs |
| 17630392900185 | Latex DD Green medium Adult (6x6), 52 pcs |
| 17630392900178 | Latex DD Green thin Adult (6x6), 52 pcs |
| 17630392900161 | Latex DD Green x-heavy Child (5x5), 52 pcs |
| 17630392900154 | Latex DD Green heavy Child (5x5), 52 pcs |
| 17630392900147 | Latex DD Green medium Child (5x5), 52 pcs |
| 17630392900130 | Latex DD Green thin Child (5x5), 52 pcs |
| 17630392900123 | Latex DD Light x-heavy Adult (6x6), 36 pcs |
| 17630392900116 | Latex DD Light heavy Adult (6x6), 36 pcs |
| 17630392900109 | Latex DD Light medium Adult (6x6), 36 pcs |
| 17630392900093 | Latex DD Light thin Adult (6x6), 36 pcs |
| 17630392900086 | Latex DD Light heavy Child (5x5), 52 pcs |
| 17630392900079 | Latex DD Light medium Child (5x5), 52 pcs |
| 17630392900062 | Latex DD Light thin Child (5x5), 52 pcs |
| 17630392900055 | Latex DD Black pre-printed thin Adult (6x6), 36 pcs |
| 17630392900048 | Latex DD Black pre-printed medium Adult (6x6), 36 pcs |
| 17630392900031 | Latex DD Black pre-printed heavy Adult (6x6), 36 pcs |
| 07630392900027 | Latex DD Black pre-printed x-heavy Adult (6x6), 36 pcs |
| 17630392900017 | Latex DD Black pre-printed medium Adult (6x6), 360 pcs |
| 07630392901239 | Flexi-Dam Framed Non-Latex Purple |
| 07630392901222 | NL FEXIDAM SAMPLE PURPLE |
| 17630392901212 | Flexi Dam Purple Framed medium Adult (6x6), 20 pcs |
| 17630392901205 | Flexi Dam Green medium Adult (6x6), 30 pcs |
| 17630392901199 | Flexi Dam Purple medium Adult (6x6), 30 pcs |
| 17630392901182 | Non-Latex DD Green medium Adult (6x6), 75 pcs |
| 17630392901175 | Non-Latex DD Green medium Adult (6x6), 15 pcs |
| 17630392901168 | Non-Latex DD Green medium Child (5x5), 15 pcs |
| 17630392901151 | Winged Standard Kit Latex w/o Instruments |
| 17630392901144 | Wingless Complete Kit Latex Premium Instruments |
| 17630392901137 | Winged Simple Dam Kit Latex Standard Instruments |
| 17630392901120 | Winged Complete Kit Latex Premium Instruments |
| 17630392901113 | Winged Complete Kit Non-latex Premium Instruments |
Trademark Results [Hysolate]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HYSOLATE 88431530 5920241 Live/Registered |
Hysolate Ltd 2019-05-15 |
 HYSOLATE 79383287 not registered Live/Pending |
Coltène/Whaledent AG 2023-10-05 |
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