Identity
- Trade Name
- EpiFaith Syringe FDA UDI
- Generic Name
- Low-resistance epidural syringe FDA UDI
- Device Name
- EpiFaith Syringe is intended for use with an epidural needle for detecting a loss of resistance, which aids a clinician in verifying needle tip placement in the epidural space. FDA UDI
- Model / Reference
- FM-01SLL FDA UDI
- Description
- EpiFaith Syringe is intended for use with an epidural needle for detecting a loss of resistance, which aids a clinician in verifying needle tip placement in the epidural space. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719875599064 FDA UDI
- 510(k) Number
- K192421 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- Low-resistance epidural syringe FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 10.2 Centimeter FDA UDI
Category: Low-resistance epidural syringe
EpiFaith Syringe by Flat Medical Co., Ltd. — Class II — MDR, MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Flat Medical Co., Ltd.
Sources (2)
- FDA UDI 43fa66b6-e761-468b-80da-219fc5399f50 37 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026