FDA UDI
In Commercial Distribution
🇺🇸 United States
HurriSeal Dentin Desensitizer Snap-N-Go Swab
DI: 00723797697115
·
Model: Snap-N-Go Swab
·
BEUTLICH PHARMACEUTICALS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
10
Pkg Device Count
1
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Basic Information
- Brand Name
- HurriSeal Dentin Desensitizer Snap-N-Go Swab
- Primary DI
- 00723797697115
- Version / Model
- Snap-N-Go Swab
- Company Name
- BEUTLICH PHARMACEUTICALS, LLC
- Labeler DUNS
- 005209325
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-01
- Public Version
- 8
- Public Version Date
- 2023-07-17
- Public Version Status
- Update
- Public Device Record Key
- e139c151-5199-43f9-914e-13b28cb3f8ad
Device Description
Single swab applicator - Dentin desensitizing liquid formula
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | Dental | 872.3200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64794 | Dental coating, tooth-desensitizing, professional | A substance intended exclusively for professional use in a healthcare facility and designed to be applied to exposed dentine (resulting from enamel erosion, breakage, tooth restoration procedure or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and/or physiological agents (e.g., cold, heat, contact, acid, bruxism) by forming a barrier within the dentine tubules. It is a mixture of synthetic and/or plant-derived ingredients in fluid form (e.g., solution, gel, mouth-rinse, resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 02723797697113 | GS1 | 3000 count bulk case | 3000 | Not in Commercial Distribution | 2021-04-30 |
| Primary | 00723797697115 | GS1 | ||||
| Package | 02723797697588 | GS1 | case of 156 12 count | 156 | Not in Commercial Distribution | 2021-04-30 |
| Package | 01723797697589 | GS1 | 12 count clamshell | 12 | Not in Commercial Distribution | 2021-04-30 |
| Package | 01723797697114 | GS1 | 2 count box | 2 | Not in Commercial Distribution | 2021-04-30 |
| Package | 01723797697473 | GS1 | 36 count box | 36 | Not in Commercial Distribution | 2021-04-30 |
| Package | 10723797697587 | GS1 | 12 count clamshell | 12 | In Commercial Distribution | |
| Package | 20723797697584 | GS1 | Case of 156 | 156 | In Commercial Distribution | |
| Package | 10723797697471 | GS1 | 36 count box | 36 | In Commercial Distribution | |
| Package | 20723797697119 | GS1 | 2 count box | 2 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-800-238-8542
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K973002 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Refrigerate if not used for long periods of time.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not freeze.
- Type
- Storage Environment Temperature
- Temperature Range
- – 25 Degrees Celsius