FDA UDI
In Commercial Distribution
🇺🇸 United States
SurgiMac
DI: D90001BX50
·
Model: 90001-Bx
·
Surgimac LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
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Basic Information
- Brand Name
- SurgiMac
- Primary DI
- D90001BX50
- Version / Model
- 90001-Bx
- Company Name
- Surgimac LLC
- Labeler DUNS
- 060635048
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2025-01-07
- Public Version
- 1
- Public Version Date
- 2025-01-15
- Public Version Status
- New
- Public Device Record Key
- 064941b6-0976-4cbf-b912-f8fe637fd690
Device Description
5% Sodium Fluoride Varnish with TCP - Bubblegum. 50 x 0.4ml unit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| LBH | Varnish, Cavity | Dental | 872.3260 | 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 |
|---|---|---|---|---|---|---|
| Unit of Use | D10590001BX50 | HIBCC | ||||
| Primary | D90001BX50 | HIBCC |