Hygenic
GUDID D661H021491
Extra Heavy 6x6 Green Ready Cut Dam
COLTENE/WHALEDENT INC
Rubber dam, Hevea-latex| Primary Device ID | D661H021491 |
| NIH Device Record Key | 1fb77f6d-d999-4b67-91e4-16585fd9b023 |
| Commercial Distribution Discontinuation | 2024-11-08 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Hygenic |
| Version Model Number | H02149 |
| Company DUNS | 622185718 |
| Company Name | COLTENE/WHALEDENT INC |
| Device Count | 36 |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 80 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D661H021490 [Unit of Use] |
| HIBCC | D661H021491 [Primary] |
FDA Product Code
| EIE | Dam, Rubber |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-11-08 |
| Device Publish Date | 2019-02-11 |
On-Brand Devices [Hygenic]
| D661H027950 | Fiesta Dam Clamp - #W2A Green |
| D661H09966C1 | FIESTA 9 COLOR CODED WINGED |
| D661H09965C1 | #14A WINGED FIESTA CLAMP |
| D661H09964C1 | #13A WINGED FIESTA CLAMP |
| D661H09963C1 | #12A WINGED FIESTA CLAMP |
| D661H09962C1 | #9 WINGED FIESTA CLAMP |
| D661H09961C1 | #8A WINGED FIESTA CLAMP |
| D661H09960C1 | #7 WINGED FIESTA CLAMP |
| D661H09959C1 | #4 WINGED FIESTA CLAMP |
| D661H09958C1 | #2A WINGED FIESTA CLAMP |
| D661H09957C1 | #2 WINGED FIESTA CLAMP |
| D661H07792C1 | 212 WINGLESS CLAMP |
| D661H05690C1 | #14 WINGED MOLAR CLAMP |
| D661H05689C1 | #3 WINGED MOLAR CLAMP |
| D661H05688C1 | #2A WINGED BICUSPID CLAMP |
| D661H03815C1 | W56 WINGLESS MOLAR CLAMP |
| D661H03814C1 | W3 WINGLESS MOLAR CLAMP |
| D661H02803C1 | #W56 WINGLESS FIESTA CLAMP |
| D661H02802C1 | #W14A WINGLESS FIESTA CLAMP |
| D661H02801C1 | FIESTA 9 COLOR CODED WINGLESS |
| D661H02800C1 | #W9 WINGLESS FIESTA CLAMP |
| D661H02799C1 | #W8A WINGLESS FIESTA CLAMP |
| D661H02798C1 | #W8 WINGLESS FIESTA CLAMP |
| D661H02797C1 | #W7 WINGLESS FIESTA CLAMP |
| D661H02796C1 | #W3 WINGLESS FIESTA CLAMP |
| D661H02795C1 | #W2A WINGLESS FIESTA CLAMP |
| D661H02794C1 | #W2 WINGLESS FIESTA CLAMP |
| D661H02775C1 | W2A WINGLESS BICUSPID CLAMP |
| D661H02774C1 | W14 WINGLESS MOLAR CLAMP |
| D661H02770C1 | W9 WINGLESS ANTERIOR CLAMP |
| D661H02769C1 | W00 WINGLESS BICUSPID CLAMP |
| D661H02768C1 | W2 WINGLESS BICUSPID CLAMP |
| D661H02767C1 | W8 WINGLESS MOLAR CLAMP |
| D661H02766C1 | W8A WINGLESS MOLAR CLAMP |
| D661H02765C1 | W7 WINGLESS MOLAR CLAMP |
| D661H02764C1 | W14A WINGLESS MOLAR CLAMP |
| D661H02763C1 | #9 WINGED ANTERIOR CLAMP |
| D661H02762C1 | #00 WINGED BICUSPID CLAMP |
| D661H02761C1 | #2 WINGED BICUSPID CLAMP |
| D661H02760C1 | #8 HYG WINGED MOLAR CLAMP |
| D661H02759C1 | #8A HYG WINGED MOLAR CLAMP |
| D661H02758C1 | #7 HYG WINGED MOLAR CLAMP |
| D661H02757C1 | #14A HYG WINGED MOLAR CLAMP |
| D661H02706C1 | #12A HYG WINGED CLAMP |
| D661H02705C1 | #13A HYG WINGED CLAMP |
| D661H02704C1 | #4 HYG WINGED CLAMP |
| D661H02703C1 | #1 HYG WINGED CLAMP |
| D661H02701C1 | SYSTEM 9 CLAMP PAK |
| D661H01054C1 | HYG TISSUE RETRACTORS |
| D661H01053C1 | B 6 HYG TISSUE RETRACTOR |
Trademark Results [Hygenic]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HYGENIC 78436768 3024860 Live/Registered |
Tennant Company 2004-06-17 |
 HYGENIC 76608566 3069817 Live/Registered |
HYGENIC INTANGIBLE PROPERTY HOLDING CO. 2004-08-20 |
 HYGENIC 73224163 1173854 Dead/Cancelled |
Hygenic Corporation, The 1979-07-20 |
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