Identity
- Trade Name
- Sterile Single-use Syringe with Needle FDA UDI
- Generic Name
- General-purpose syringe/needle FDA UDI
- Model / Reference
- 5mL LL 23G×1 1/4" (0.6mm×32mm) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06920756729267 FDA UDI
- 510(k) Number
- K163161 FDA UDI
- FDA Product Code
- FMI FDA UDIFMF FDA UDI
- GMDN Term
- General-purpose syringe/needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 FDA UDI880.5860 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
Category: General-purpose syringe/needle
Sterile Single-use Syringe with Needle by Jiangxi Hongda Medical Equipment Group Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as General-purpose syringe/needle.
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- BAIXIN — Anhui Kangda Medical Products Co., Ltd. · Class II
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- RELI® — MYCO MEDICAL SUPPLIES INC. · Class II
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
- Jiangxi Hongda Medical Equipment Group Co., Ltd.
Sources (1)
- FDA UDI cc0abeb6-d11b-438d-8ab3-89beee18017d 33 fields · synced May 31, 2026