FDA UDI
In Commercial Distribution
🇺🇸 United States
Prosthetic Silicone Materials
DI: 05060483012452
·
Model: CoForm Soft Impression Material – 40g
·
TECHNOVENT LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Prosthetic Silicone Materials
- Primary DI
- 05060483012452
- Version / Model
- CoForm Soft Impression Material – 40g
- Catalog Number
- M517
- Company Name
- TECHNOVENT LIMITED
- Labeler DUNS
- 225835156
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-22
- Public Version
- 1
- Public Version Date
- 2024-07-30
- Public Version Status
- New
- Public Device Record Key
- cd7c1ba7-20fa-4596-8eed-ae83759005b2
Device Description
Cartridge based silicone materials for taking external impressions to aid the construction of prostheses.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| GBI | Material, External Aesthetic Restoration, Used With Adhesive | General, Plastic Surgery | 878.3800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35866 | Silicone dental impression material | An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060483012452 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
- Type
- Special Storage Condition, Specify
- Special Conditions
- The Coform impression materials are supplied non-sterile in duel dispensing cartridges and it is recommended that they are stored in their original containers. Store out of direct sunlight.