FDA UDI
In Commercial Distribution
🇺🇸 United States
Silicone Sizer Set for ePTFE Nasal Dorsum, Pointed
DI: M724ESNPSIZNS1
·
Model: ESNP-SIZ
·
IMPLANTECH ASSOCIATES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Silicone Sizer Set for ePTFE Nasal Dorsum, Pointed
- Primary DI
- M724ESNPSIZNS1
- Version / Model
- ESNP-SIZ
- Catalog Number
- ESNP-SIZ-NS
- Company Name
- IMPLANTECH ASSOCIATES, INC.
- Labeler DUNS
- 784664955
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-14
- Public Version
- 1
- Public Version Date
- 2019-06-24
- Public Version Status
- New
- Public Device Record Key
- ca487519-7b88-4442-b6b0-1bc2efe991b2
Device Description
Silicone Sizer Set for ePTFE Nasal Dorsum, Pointed
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FZE | Prosthesis, Nose, Internal | General, Plastic Surgery | 878.3680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31038 | Nasal implant, synthetic polymer, non-bioabsorbable | A non-bioabsorbable device intended to be implanted beneath the skin of the nose (e.g., between the nasal mucosa and the cartilage) to augment or restore the cosmetic appearance and/or function of the nose, by providing structural support to the cartilage. It is a shaped device made of synthetic polymer materials (e.g., solid silicone rubber). | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M724ESNPSIZNS1 | HIBCC |
Customer Contacts
- Phone
- 1-800-733-0833
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141027 | 000 |