Identity
- Trade Name
- Nasal Septal Button FDA UDI
- Generic Name
- Nasal septal button FDA UDI
- Device Name
- Size: 3.2 cm; Type: Clear FDA UDI
- Model / Reference
- 60-101 FDA UDI
- Description
- Size: 3.2 cm; Type: Clear FDA UDI
Identifiers
- Catalog Number
- 60-101 FDA UDI
- Primary DI / UDI-DI
- EBES601010 FDA UDI
- 510(k) Number
- K972060 FDA UDI
- FDA Product Code
- LFB FDA UDI
- GMDN Term
- Nasal septal button FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 32 Millimeter FDA UDI
Category: Nasal septal button
Nasal Septal Button by Boston Medical Products, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nasal septal button.
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · U
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · U
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · U
- Invotec Nasal Septal Button — Invotec International, Inc. · U
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · U
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · U
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · U
- InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · U
Cleared under the same submission
K972060 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Boston Medical Products, Inc.
Sources (1)
- FDA UDI 368e3c15-96d6-415c-84d6-439ca826950b 38 fields · synced Jun 9, 2026