FDA UDI
In Commercial Distribution
🇺🇸 United States
HSEU
DI: 00304040151433
·
Model: 5702541
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- HSEU
- Primary DI
- 00304040151433
- Version / Model
- 5702541
- Catalog Number
- 5702541
- Company Name
- HENRY SCHEIN, INC.
- Labeler DUNS
- 012430880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-12
- Public Version
- 2
- Public Version Date
- 2021-12-06
- Public Version Status
- Update
- Public Device Record Key
- d31a82a4-61e7-4922-9fb6-5e88ddd98646
Device Description
An aqueous based 15.5% Ferric Sulfate solution, which is excellent for soaking retraction cord, eliminating sulcular fluid contamination, aiding gingival retraction and reducing mucous membrane inflammation.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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 |
|---|---|---|---|---|
| MVL | CORD, RETRACTION | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46423 | Gingival retraction solution | A liquid substance used in dentistry to induce gingival retraction by in situ impregnation of a non-medicated gingival retraction cord. It induces contraction of the upper strata of the free gingiva typically through the action of an astringent agent (e.g., aluminium chloride). This device may also induce a local stasis of gingival exudates and gingival haemorrhages. 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 | 10304040151430 | GS1 | Inner Pack | 20 | In Commercial Distribution | |
| Primary | 00304040151433 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store between 2-30C