FDA UDI
In Commercial Distribution
🇺🇸 United States
PEAKOSIL
DI: 08800026400127
·
Model: NS005P-1
·
NEOSIL Co., Ltd
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- PEAKOSIL
- Primary DI
- 08800026400127
- Version / Model
- NS005P-1
- Company Name
- NEOSIL Co., Ltd
- Labeler DUNS
- 690409169
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-03
- Public Version
- 4
- Public Version Date
- 2021-06-30
- Public Version Status
- Update
- Public Device Record Key
- 4117644e-223b-4bd7-9e40-cd6ebfaa441f
Device Description
Product Name: PEAKOSIL One-Time Putty This product is a convenience kit of Putty(MSP). This product changed only in packaging materials from Putty. These changes don't cause any change from the original functions of Putty. Importer as Retailer is exempt from FDA’S medical device, Establishment Registration, under 21 CFR, 807.65 (e) and (i).
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| ELW | Material, Impression | Dental | 872.3660 | 2 |
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 | 08800026400127 | GS1 | ||||
| Package | 18800026400124 | GS1 | 10 | In Commercial Distribution | ||
| Package | 08800026400240 | GS1 | Box | 10 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K152180 | 000 |