Identity
- Trade Name
- Metier FDA UDI
- Generic Name
- Tuberculin/allergy syringe/needle, basic FDA UDI
- Device Name
- The Safety Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin. The Safety sheath of Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential or syringe reuse. FDA UDI
- Model / Reference
- 1ml 27Gx1/2 FDA UDI
- Description
- The Safety Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin. The Safety sheath of Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential or syringe reuse. FDA UDI
Identifiers
- Catalog Number
- SSTBSTL0127012 FDA UDI
- Primary DI / UDI-DI
- 06971564467278 FDA UDI
- 510(k) Number
- K192551 FDA UDI
- FDA Product Code
- FMF FDA UDIMEG FDA UDI
- GMDN Term
- Tuberculin/allergy syringe/needle, basic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 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
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 1 Milliliter FDA UDINeedle Gauge — 27 Gauge FDA UDILength — 0.5 Inch FDA UDI
Category: Tuberculin/allergy syringe/needle, basic
Metier by Jiangsu Caina Medical Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tuberculin/allergy syringe/needle, basic.
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC · Class II
- Metier — Jiangsu Caina Medical Co., Ltd · Class II
Cleared under the same submission
K192551 also covers:
- CAINA — Jiangsu Caina Medical Co., Ltd
- CAINA — Jiangsu Caina Medical Co., Ltd
- CAINA — Jiangsu Caina Medical Co., Ltd
- CAINA — Jiangsu Caina Medical Co., Ltd
- Metier — Jiangsu Caina Medical Co., Ltd
- Medline — MEDLINE INDUSTRIES, INC.
- Ceros — RHINO MEDICAL SUPPLY INC
- Ceros — RHINO MEDICAL SUPPLY INC
- Ceros — RHINO MEDICAL SUPPLY INC
- Ceros — RHINO MEDICAL SUPPLY INC
- Ceros — RHINO MEDICAL SUPPLY 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
- Jiangsu Caina Medical Co., Ltd
Sources (1)
- FDA UDI 99b54469-eb9d-42f8-9d0d-fdeef2b81f31 36 fields · synced Jun 1, 2026