Identity
- Trade Name
- EZ-Ject FDA UDI
- Generic Name
- General-purpose endoscopic needle, single-use FDA UDI
- Device Name
- Injection Needle FDA UDI
- Model / Reference
- 1186-01 FDA UDI
- Description
- Injection Needle FDA UDI
Identifiers
- Catalog Number
- 1186-01 FDA UDI
- Primary DI / UDI-DI
- 00816734023365 FDA UDI
- FDA Product Code
- FBK FDA UDI
- GMDN Term
- General-purpose endoscopic needle, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
No
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 22 Gauge FDA UDI
Category: General-purpose endoscopic needle, single-use
EZ-Ject by Diversatek Healthcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose endoscopic needle, single-use.
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- ZKSK — Beijing ZKSK Technology Co., Ltd · Class II
- Injectra, ScleroTip — Medi-Globe Corporation · Class II
- 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 (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 II | Pending data |
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Manufacturer
- Manufacturer
- Diversatek Healthcare
Sources (1)
- FDA UDI 3f2d41cb-ef94-464a-9207-f42a9dba2e1c 36 fields · synced May 30, 2026