FDA UDI
In Commercial Distribution
🇺🇸 United States
Henry Schein
DI: H65810128200
·
Model: 1012820
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Henry Schein
- Primary DI
- H65810128200
- Version / Model
- 1012820
- Catalog Number
- 1012820
- Company Name
- HENRY SCHEIN, INC.
- Labeler DUNS
- 012430880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 1886d29b-0cc1-41ac-9f0c-098477092d49
Device Description
PREMIUM DNT BASE 99 HC (1 LB 4 PER CASE)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- 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 |
|---|---|---|---|---|
| EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING | Dental | 872.3760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16729 | Denture base resin, heat-cured | A resin that requires heat for polymerization intended to be used in the dental laboratory to manufacture a complete or partial denture base (the portion of a denture that rests on the oral mucosa and retains the artificial teeth). It usually consists of an acrylic monomer of methyl methacrylate (typically supplied as a powder) that becomes a polymer (polymethylmethacrylate or PMMA) when mixed with a catalyst such as benzoylperoxide (typically supplied as a liquid). Reinforcing fillers may be included in the resin to increase its strength and/or durability. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | H65810128201 | HIBCC | CASE | 4 | In Commercial Distribution | |
| Primary | H65810128200 | HIBCC |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 1 | Pound |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 16 – 26 Degrees Celsius