FDA UDI
In Commercial Distribution
🇺🇸 United States
Hysolate
DI: 07630392900515
·
Model: H06523
·
Dent4You AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Hysolate
- Primary DI
- 07630392900515
- Version / Model
- H06523
- Company Name
- Dent4You AG
- Labeler DUNS
- 480152811
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-28
- Public Version
- 1
- Public Version Date
- 2023-03-08
- Public Version Status
- New
- Public Device Record Key
- c8344f64-a3c1-4098-a777-a623197dd229
Device Description
Wedjets Stabilization cord Latex large, 2.1 m
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| EIE | Dam, Rubber | Dental | 872.6300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45079 | Rubber dam stabilization cord, Hevea-latex | A length of elastomeric material made of Hevea natural rubber latex (NRL) designed to stabilize/secure a rubber dam in the oral cavity during routine operative and endodontic procedures. It can be used wedge-like between the teeth and/or tied around a tooth to anchor a rubber dam to the cervical region of an exposed tooth. This device is available in a variety of sizes and may help reduce the trauma and discomfort perceived by some patients caused through the use of metal clamps. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07630392900515 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 26 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from heat.
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 26 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry.