Identity
- Trade Name
- Metier FDA UDI
- Generic Name
- Insulin syringe/needle, safety FDA UDI
- Device Name
- Safelock Disposable Insulin Syringe is intended to inject U-100 insulin into the human body and aid in the prevention of accidental needle stick injuries. FDA UDI
- Model / Reference
- 0.5ml 31Gx5/16 FDA UDI
- Description
- Safelock Disposable Insulin Syringe is intended to inject U-100 insulin into the human body and aid in the prevention of accidental needle stick injuries. FDA UDI
Identifiers
- Catalog Number
- SSISTL005310516 FDA UDI
- Primary DI / UDI-DI
- 06971564467254 FDA UDI
- 510(k) Number
- K150758 FDA UDI
- FDA Product Code
- FMF FDA UDIMEG FDA UDI
- GMDN Term
- Insulin syringe/needle, safety 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
No
FDA UDI
Over-the-Counter
Yes
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 — 0.5 Milliliter FDA UDINeedle Gauge — 31 Gauge FDA UDILength — 0.3125 Inch FDA UDI
Category: Insulin syringe/needle, safety
Metier by Jiangsu Caina Medical Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Insulin syringe/needle, safety.
- SecureSafe Syringe With Safety Needle — Dynarex Corp. · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- RELI — MYCO MEDICAL SUPPLIES INC. · Class II
- ONE-CARE Safety Pen Needles 30G x 8mm, Yellow, — MediVena, LLC · Class II
- Endure — ENDURE INDUSTRIES, INC. · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- Disposable Insulin Syringe — Berpu Medical Technology Co., Ltd · Class II
- RELI — MYCO MEDICAL SUPPLIES INC. · Class II
Cleared under the same submission
K150758 also covers:
- Glucertain — CellEra, LLC
- Glucertain — CellEra, LLC
- Secure Safe Allergy Tray — Dynarex Corp.
- SecureSafe Tuberculin Safety Syringe — Dynarex Corp.
- SecureSafe Tuberculin Safety Syringe — Dynarex Corp.
- SecureSafe Tuberculin Safety Syringe — Dynarex Corp.
- Metier — Jiangsu Caina Medical Co., Ltd
- Metier — Jiangsu Caina Medical Co., Ltd
- Metier — Jiangsu Caina Medical Co., Ltd
- MEDLINE — MEDLINE INDUSTRIES, INC.
- Medline — MEDLINE INDUSTRIES, INC.
- ONE-CARE Insulin Safety Syringes — MediVena, LLC
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 892d7299-45d2-409c-a2b1-fba7e267a7db 36 fields · synced May 30, 2026