FDA UDI
In Commercial Distribution
🇺🇸 United States
Henry Schein
DI: 00304040005101
·
Model: 1011747
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Henry Schein
- Primary DI
- 00304040005101
- Version / Model
- 1011747
- Catalog Number
- 1011747
- 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
- a62f06ef-85cf-4cb3-b627-7d9840062c14
Device Description
ZOE Temporary Cement
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| EMB | ZINC OXIDE EUGENOL | Dental | 872.3275 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38778 | Temporary dental filling material | A dental material of various chemical compositions [e.g., calcium hydroxide (Ca(OH)2), methyl methacrylate] used to temporarily fill tooth cavities to preserve the tooth and its pulp. It is typically x-ray visible and may be used for temporary tooth filling with direct/indirect capping, root treatment with pulp capping, vital amputations, treatment of extirpation, decayed pulps, gangrene, fistulae, sensitive tooth crevices, superficial enamel caries, and marginal periodontium inflammation. After application, this device cannot be reused. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00304040005101 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 45 | Gram | |
| Device Size Text, specify | Catalyst | ||
| Weight | 20 | Gram | |
| Device Size Text, specify | Base |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 24 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 75 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep out of sun