Identity
- Trade Name
- EndoTNeedle EUDAMEDFDA UDI
- Generic Name
- General-purpose endoscopic needle, single-use FDA UDI
- Device Name
- Endoscopic injection needle EUDAMEDFDA UDI
- Model / Reference
- ET1323 EUDAMEDFDA UDIET1322 EUDAMEDFDA UDIET1301 EUDAMEDFDA UDIET1300 FDA UDI
- Description
- Endoscopic injection needle FDA UDI
Identifiers
- Catalog Number
- ET1300 FDA UDIET1323 FDA UDIET1322 FDA UDIET1301 FDA UDI
- Primary DI / UDI-DI
- 00816207021164 EUDAMEDFDA UDI00816207021157 EUDAMEDFDA UDI00816207021058 EUDAMEDFDA UDI00816207021010 FDA UDI
- Basic UDI-DI
- B-00816207021157 EUDAMEDB-00816207021058 EUDAMEDB-00816207021164 EUDAMED
- FDA Product Code
- FBK FDA UDI
- EMDN Code
- G03020101 DIGESTIVE ENDOSCOPY, SINGLE-LUMEN NEEDLES EUDAMED
- GMDN Term
- General-purpose endoscopic needle, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Malta 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
- Needle Gauge — 25 Gauge FDA UDILength — 160 Centimeter FDA UDIOuter Diameter — 2.5 Millimeter FDA UDILength — 230 Centimeter FDA UDINeedle Gauge — 23 Gauge FDA UDI
Category: General-purpose endoscopic needle, single-use
EndoTNeedle by Endo-Therapeutics, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose endoscopic needle, single-use.
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- Single Use Injector NM600/610 — Olympus Medical Systems Corporation · Class II
- Single Use Aspiration Needle NA-U401SX — Olympus Medical Systems Corporation · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class I
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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Endo-Therapeutics, Inc.
Sources (7)
- FDA UDI df4c940a-2b48-4fa4-b1c4-8566eca2cdcb 37 fields · synced Jul 25, 2026
- FDA UDI a61922f0-37bd-4cd1-8ffa-899b27b7be9b 37 fields · synced May 30, 2026
- FDA UDI 672fcb92-bdb4-41d7-bdda-fb4eda3837b6 37 fields · synced May 30, 2026
- FDA UDI 3ceb9bc1-e0f2-4383-97d0-d8b2b42b56e3 37 fields · synced May 30, 2026
- EUDAMED 06b3001d-5c36-434c-a0cd-efcfa6da6561 61 fields · synced Jul 17, 2026
- EUDAMED a7183c40-7d2b-4bf9-8827-0ac7d094bc6f 61 fields · synced Jul 22, 2026
- EUDAMED 9fd8ecf1-154f-45e8-aa06-7511bb330e26 61 fields · synced Jul 25, 2026