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SOL-CARE™ Safety Blood Collection Needle w/Pre-attached Holder
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 110201030006Model Safety Blood Collection/Infusion Butterfly Needles (with pre-attached holder or without)
Identity
- Trade Name
- SOL-CARE Safety Blood Collection Needle w/Pre-attached Holder EUDAMEDSOL-CARE™ Safety Blood Collection Needle w/Pre-attached Holder FDA UDI
- Generic Name
- Needle guard FDA UDI
- Device Name
- SOL-CARE Safety Blood Collection Needle w/Pre-attached Holder 23G*3/4*12inch FDA UDI
- Model / Reference
- 110201030006 EUDAMEDFDA UDISafety Blood Collection/Infusion Butterfly Needles (with pre-attached holder or without) EUDAMED
- Description
- SOL-CARE Safety Blood Collection Needle w/Pre-attached Holder 23G*3/4*12inch FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00818392015607 EUDAMEDFDA UDI
- Basic UDI-DI
- 081006243SBC1YC EUDAMED
- Direct Marketing DI
- 00818392015607 EUDAMED
- FDA Product Code
- JKA FDA UDI
- EMDN Code
- A01010201 BUTTERFLY NEEDLES, WITH SAFETY SYSTEMS EUDAMED
- GMDN Term
- Needle guard FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1675 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
- Length — 20 Millimeter FDA UDINeedle Gauge — 23 Gauge FDA UDI
Category: Needle guard
SOL-CARE™ Safety Blood Collection Needle w/Pre-attached Holder by Sol-Millennium Medical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Needle guard.
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
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- Portex — ICU MEDICAL, INC. · Class II
- Jelco — ICU MEDICAL, INC. · Class II
- DropSafe Syringe with Safety Needle — HTL STREFA S A · Class II
- Monoject — Cardinal Health 200, LLC · Class II
- EasyPoint® — Retractable Technologies, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sol-Millennium Medical, Inc.
Sources (2)
- FDA UDI 04354869-3331-4f29-9a43-c4040c6ee2ec 35 fields · synced Jul 11, 2026
- EUDAMED 49fcc7cd-8ebb-46dd-80ce-26d6fcc09941 61 fields · synced Jul 11, 2026