Identity
- Trade Name
- Medline FDA UDI
- Generic Name
- Medication cartridge syringe, safety-needle FDA UDI
- Device Name
- SAFETY NEEDLE,19GX1.5" FDA UDI
- Model / Reference
- SYRS100197 FDA UDI
- Description
- SAFETY NEEDLE,19GX1.5" FDA UDI
Identifiers
- Catalog Number
- SYRS100197 FDA UDI
- Primary DI / UDI-DI
- 30888277220854 FDA UDI
- 510(k) Number
- K112057 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- Medication cartridge syringe, safety-needle 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
Category: Medication cartridge syringe, safety-needle
Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Medication cartridge syringe, safety-needle.
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Cleared under the same submission
K112057 also covers:
- EZ FLO — AIR-TITE PRODUCTS COMPANY, INC.
- EZ FLO — AIR-TITE PRODUCTS COMPANY, INC.
- EZ FLO — AIR-TITE PRODUCTS COMPANY, INC.
- EZ FLO — AIR-TITE PRODUCTS COMPANY, INC.
- EZ FLO — AIR-TITE PRODUCTS COMPANY, INC.
- EZ FLO — AIR-TITE PRODUCTS COMPANY, INC.
- EZ FLO — AIR-TITE PRODUCTS COMPANY, INC.
- EZ FLO — AIR-TITE PRODUCTS COMPANY, INC.
- AHS — American Health Service Sales Corporation
- AHS — American Health Service Sales Corporation
- AHS — American Health Service Sales Corporation
- AHS — American Health Service Sales Corporation
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medline Industries, Inc.
Sources (1)
- FDA UDI 6c1c44e1-0cd0-4b12-b7fc-76385a71f00c 36 fields · synced May 30, 2026