Identity
- Trade Name
- ProTector FDA UDI
- Generic Name
- Surgical instrument containment holder, single-use, non-sterile FDA UDI
- Device Name
- Needle Sheath Prop FDA UDI
- Model / Reference
- PNS100 FDA UDI
- Description
- Needle Sheath Prop FDA UDI
Identifiers
- Catalog Number
- PNS100-1 FDA UDI
- Primary DI / UDI-DI
- H816PNS1001 FDA UDI
- 510(k) Number
- K052725 FDA UDI
- FDA Product Code
- FMI FDA UDI
- GMDN Term
- Surgical instrument containment holder, single-use, non-sterile 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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: Surgical instrument containment holder, single-use, non-sterile
ProTector by Certol International, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical instrument containment holder, single-use, non-sterile.
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Cleared under the same submission
K052725 also covers:
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
- Certol International, Llc
Sources (1)
- FDA UDI 4c1d66fd-45de-455e-a7da-a1c8a6215dfe 35 fields · synced May 31, 2026