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Bivalve Internal Nasal Splint
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 20-10530Model Internal Nasal SplintRef AMT901-10Ref 20-10650SRef AMT801-1/1Ref AMT901-2Ref 20-10665SRef AMT601-5Ref 20-10650
Identity
- Trade Name
- Bivalve Internal Nasal Splint EUDAMEDFDA UDI
- Generic Name
- Intranasal splint, non-biodegradable FDA UDI
- Device Name
- Internal Nasal Splint EUDAMEDBivalve Internal Nasal Splint, w/o Split, Large 0.5mm FDA UDIBivalve Internal Nasal Splint, Large 0.50mm, Singles Fluroplastic FDA UDIBivalve Internal Nasal Splint, Standard, 0.25mm, Fluoroplastic FDA UDIBivalve Internal Nasal Splint, Standard, 0.25mm, Singles Fluoroplastic FDA UDI
- Model / Reference
- 20-10665S EUDAMEDFDA UDI20-10650 EUDAMEDFDA UDI20-10650S EUDAMEDFDA UDIInternal Nasal Splint EUDAMED20-10530 EUDAMEDAMT901-10 EUDAMEDAMT801-1/1 EUDAMEDAMT901-2 EUDAMEDAMT601-5 EUDAMED20-10664 FDA UDI
- Description
- Bivalve Internal Nasal Splint, w/o Split, Large 0.5mm FDA UDIBivalve Internal Nasal Splint, Large 0.50mm, Singles Fluroplastic FDA UDIBivalve Internal Nasal Splint, Standard, 0.25mm, Fluoroplastic FDA UDIBivalve Internal Nasal Splint, Standard, 0.25mm, Singles Fluoroplastic FDA UDI
Identifiers
- Catalog Number
- 20-10664 FDA UDI20-10665S FDA UDI20-10650 FDA UDI20-10650S FDA UDI
- Primary DI / UDI-DI
- 00818501020997 EUDAMEDFDA UDI00818501020928 EUDAMEDFDA UDI00818501020935 EUDAMEDFDA UDI00818501023127 EUDAMED00818501022977 EUDAMED00818501022816 EUDAMED00818501022878 EUDAMED00818501022847 EUDAMED00818501021024 FDA UDI
- Basic UDI-DI
- 081850102IntNasalSplintHX EUDAMED
- FDA Product Code
- LYA FDA UDI
- EMDN Code
- Q0399 ENT DEVICES - OTHER EUDAMED
- GMDN Term
- Intranasal splint, non-biodegradable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.4780 FDA UDI
- Market of Registration
- Austria EUDAMEDGermany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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 UDIFDA UDI
Category: Intranasal splint, non-biodegradable
Bivalve Internal Nasal Splint by Invotec International, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Intranasal splint, non-biodegradable.
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- Custom Nasal Splint — Boston Medical Products, Inc. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Invotec International, Inc.
Sources (12)
- FDA UDI 6bb75c5c-7d28-42d3-80ce-ec64381a1b3e 34 fields · synced Aug 4, 2026
- FDA UDI 1d62e346-923f-47dd-9b5b-f16969ec89ae 34 fields · synced May 30, 2026
- FDA UDI a143384c-3519-4dbd-928a-94460db79d7e 34 fields · synced May 30, 2026
- FDA UDI ab28170b-3d37-4294-a71a-10c08b421c2f 34 fields · synced May 30, 2026
- EUDAMED 270efffc-014a-4793-8bc3-d58a86a55177 61 fields · synced Jul 9, 2026
- EUDAMED 881e882f-cbef-4298-8a78-28a4feecb457 61 fields · synced Jul 9, 2026
- EUDAMED 31c34f1d-9c59-41b1-88e2-0fa41e3bb646 61 fields · synced Jul 12, 2026
- EUDAMED d91544f9-ded3-47f1-8fa6-505a3ee8a103 61 fields · synced Jul 14, 2026
- EUDAMED c74b350a-3133-493e-818b-4e6b5a315d38 61 fields · synced Jul 22, 2026
- EUDAMED 5030455e-1fc5-4e33-af10-780d4599e4aa 61 fields · synced Jul 28, 2026
- EUDAMED 8ed6a75c-dd34-468d-9069-ddecb696ef06 61 fields · synced Jul 29, 2026
- EUDAMED fc712772-7a93-4f20-84e4-99e4e4f4f14e 61 fields · synced Aug 4, 2026