FDA UDI
In Commercial Distribution
🇺🇸 United States
Prosthetic Silicone Materials
DI: 05060483012698
·
Model: Extrinsic Sealant - Part A (10g) and Part B (10g)
·
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
- 05060483012698
- Version / Model
- Extrinsic Sealant - Part A (10g) and Part B (10g)
- Catalog Number
- P799/A and P799/B
- 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
- 138c4547-8c48-4283-a3fa-c9ec56960141
Device Description
Technovent Extrinsic Colours and Sealant are products to extrinsically colour and seal colours onto processed prostheses.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| 16730 | Dental appliance fabrication material, resin | A resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060483012698 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- The extrinsic colours and sealant are supplied non-sterile in plastic bottles and it is recommended that they are stored in their original containers. Store out of direct sunlight.
- 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.