Identity
- Trade Name
- KBMED FDA UDI
- Generic Name
- Hypodermic needle, single-use FDA UDI
- Device Name
- Safety Needle, 23Gx1", box of 100pcs FDA UDI
- Model / Reference
- SN1B-2325 FDA UDI
- Description
- Safety Needle, 23Gx1", box of 100pcs FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10810100050112 FDA UDI
- 510(k) Number
- K211329 FDA UDI
- FDA Product Code
- FMI FDA UDI
- GMDN Term
- Hypodermic needle, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 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
Category: Hypodermic needle, single-use
Kbmed by KB Medical (group), Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hypodermic needle, single-use.
- Monoject — Cardinalhealth · Class II
- Pinpoint GT — Bard Access Systems, Inc. · Class II
- Safety Needle — Jiangsu Micsafe Medical Technology Co., Ltd · Class IIa
- Syringe w/Needle, Non-Toxic, 25G x 1", Luer Lock — Dynarex Corp. · Class II
- Yeso med — WUXI YUSHOU MEDICAL APPLIANCES CO., LTD. · Class II
- EasyTouch — MHC Medical Products · Class II
- STERiJECT TM — TSK LABORATORY, JAPAN · Class II
- Comfort EZ Pro — S.D.I. USA, INC. · Class II
Cleared under the same submission
K211329 also covers:
- KBMED — KB Medical (group), Inc.
- KBMED — KB Medical (group), Inc.
- KBMED — KB Medical (group), Inc.
- KBMED — KB Medical (group), Inc.
- KBMED — KB Medical (group), Inc.
- KBMED — KB Medical (group), Inc.
- KBMED — KB Medical (group), Inc.
- KBMED — KB Medical (group), Inc.
- KBMED — KB Medical (group), Inc.
- KBMED — KB Medical (group), Inc.
- KBMED — KB Medical (group), Inc.
- KBMED — KB Medical (group), Inc.
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
- KB Medical (group), Inc.
Sources (1)
- FDA UDI b0c6b367-98f7-49d3-87ed-9e796916bafb 34 fields · synced Jun 1, 2026