Identity
- Trade Name
- Gyrus ACMI FDA UDI
- Generic Name
- Intranasal splint, non-biodegradable FDA UDI
- Device Name
- NEIMAN SEPTAL SPLINT SILICONE (2/PK) FDA UDI
- Model / Reference
- 140441 FDA UDI
- Description
- NEIMAN SEPTAL SPLINT SILICONE (2/PK) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925035119 FDA UDI
- FDA Product Code
- LYA FDA UDI
- GMDN Term
- Intranasal splint, non-biodegradable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4780 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intranasal splint, non-biodegradable
Gyrus ACMI by Gyrus Acmi, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intranasal splint, non-biodegradable.
- Compresses stériles de gaze hydrophile 8cm x 7cm 17 fils/cm2 - 12 plis sachet de 5 compresses — Adhe-Els SA. · Class I
- Intranasl Splint INS — Boston Medical Products, Inc. · Class I
- Sterile Gauze Balls — Kingstar Medical (Xianning) Co., LTD · Class I
- Sterile Absorbent Pads — GS Medical · Class I
- Sterile Gauze Sponges — JIANGSU FEIXIA MEDICAL PRODUCTS CO., LTD · Class I
- Sterile Pad 9cm x 15cm one fold Without X-Ray ETO sterile — ERMED TIP MEDİKAL TİCARET A.Ş. · Class IIa
- Gauze Swabs — Jiujiang HuaDa Medical Dressing Co., Ltd. · Class I
- Custom Nasal Splint — Boston Medical Products, Inc. · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gyrus Acmi, Inc.
Sources (1)
- FDA UDI b366f1ea-7b2e-442e-9d42-631fd232af2a 33 fields · synced May 31, 2026