Identity
- Trade Name
- Deflux Metal Needle EUDAMEDFDA UDI
- Generic Name
- Submucosal injection needle FDA UDI
- Device Name
- DEFLUX METAL NEEDLE (1 X32CM) EUDAMEDDeflux metal needle FDA UDI
- Model / Reference
- DX1202 EUDAMED3.7 FR x 23 G (tip) x 350 mm FDA UDI
- Description
- Deflux metal needle FDA UDI
Identifiers
- Catalog Number
- DX1201 FDA UDI
- Primary DI / UDI-DI
- 00850004725122 EUDAMED00850004725023 FDA UDI
- Basic UDI-DI
- B-00850004725122 EUDAMED
- PMA Number
- P000029 FDA UDI
- FDA Product Code
- LNM FDA UDI
- EMDN Code
- A019099 NEEDLES FOR OTHER PROCEDURES - OTHER EUDAMED
- GMDN Term
- Submucosal injection needle FDA UDI
Classification
- Device Class
- Class III EUDAMEDFDA UDI
- Market of Registration
- Ireland 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
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
Dimensions & Sizes
- Size
- Length — 350 Millimeter FDA UDINeedle Gauge — 23 Gauge FDA UDI
Category: Submucosal injection needle
Deflux Metal Needle by Palette Life Sciences — Class III — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Submucosal injection needle.
- Disposable Injection Needles — Ningbo Xinwell Medical Technology Co., Ltd. · Class II
- Injection Needle — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Disposable Injection Needles — Ningbo Xinwell Medical Technology Co., Ltd. · Class II
- Disposable Injection Needles — Ningbo Xinwell Medical Technology Co., Ltd. · Class II
- Disposable Injection Needles — Ningbo Xinwell Medical Technology Co., Ltd. · Class II
- Injection Needle — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Disposable Injection Needles — Ningbo Xinwell Medical Technology Co., Ltd. · Class II
- Disposable Injection Needles — Ningbo Xinwell Medical Technology Co., Ltd. · Class II
Cleared under the same submission
P000029 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class III | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Palette Life Sciences
Sources (2)
- FDA UDI 8c024a4e-a6eb-49b0-8d57-1ea470be0b8f 37 fields · synced Jul 14, 2026
- EUDAMED 8ba7bfe3-c1e2-42d0-a8a0-0ef829188dd7 61 fields · synced Jul 14, 2026