FDA UDI
In Commercial Distribution
🇺🇸 United States
SeptAlign
DI: 00860011696308
·
Model: FG-0032
·
SPIRAIR, INC.
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SeptAlign
- Primary DI
- 00860011696308
- Version / Model
- FG-0032
- Catalog Number
- SPLN001
- Company Name
- SPIRAIR, INC.
- Labeler DUNS
- 111289449
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-16
- Public Version
- 2
- Public Version Date
- 2025-12-25
- Public Version Status
- Update
- Public Device Record Key
- 035747a0-2628-4205-abd1-fad4fe4aa059
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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NHB | Polymer, Ear, Nose And Throat, Synthetic, Absorbable | Ear, Nose, Throat | 874.3620 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62156 | Nasal cartilage support implant introducer | A hand-held manual surgical instrument intended to introduce a nasal cartilage support implant into the nasal soft tissues (e.g., between the nasal mucosa and the cartilage). It is in the form of a syringe-like tool with a plunger and a stainless steel cannula designed to be inserted through the nasal mucosa tissue, via the nasal cavity, to deploy the implant. This is a single-use device. | No | Active |
| 62157 | Nasal cartilage support implant, bioabsorbable | A 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 to prevent nasal obstruction. It is a shaped device made of synthetic polymer materials [e.g., poly(L-lactide-co-D, L-lactide)] designed to gradually disintegrate following implantation. Dedicated devices intended to assist implantation through puncture of mucosal tissues may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860011696308 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K233569 | 000 |