Identity
- Trade Name
- NeedleSafe FDA UDI
- Generic Name
- Needle recapping device, reusable FDA UDI
- Device Name
- NeedleSafe II is a medical safety device that enables single-handed recapping of needles, I.V. catheters and phlebotomy sets. Mounted horizontally or vertically, NeedleSafe II provides vital protection whenever and wherever needed. Examples of service locations include: At every bedside On medication carts Injection trays Phlebotomy trays Critical Care Units Endoscopy Suites Pharmacy Anesthesia/Surgery Pathology Emergency Department Psychiatric wards NeedleSafe II may be steam autoclaved, gas sterilized, or disinfected by wiping with or soaking in alcohol. FDA UDI
- Model / Reference
- II FDA UDI
- Description
- NeedleSafe II is a medical safety device that enables single-handed recapping of needles, I.V. catheters and phlebotomy sets. Mounted horizontally or vertically, NeedleSafe II provides vital protection whenever and wherever needed. Examples of service locations include: At every bedside On medication carts Injection trays Phlebotomy trays Critical Care Units Endoscopy Suites Pharmacy Anesthesia/Surgery Pathology Emergency Department Psychiatric wards NeedleSafe II may be steam autoclaved, gas sterilized, or disinfected by wiping with or soaking in alcohol. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00725030550102 FDA UDI
- 510(k) Number
- K936235 FDA UDI
- FDA Product Code
- FMI FDA UDI
- GMDN Term
- Needle recapping device, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Needle recapping device, reusable
NeedleSafe by Ingenious Technologies Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Ingenious Technologies Corp.
Sources (1)
- FDA UDI 840556f4-5de5-4c03-b107-c9fdfd7f37b1 35 fields · synced May 31, 2026