Identity
- Trade Name
- 18PO - Class A OutDoor - Poly Orange FDA UDI
- Generic Name
- Adhesive bandage FDA UDI
- Device Name
- 18PO - Class A OutDoor - Poly Orange FDA UDI
- Model / Reference
- K616-012 FDA UDI
- Description
- 18PO - Class A OutDoor - Poly Orange FDA UDI
Identifiers
- Catalog Number
- K616-012 FDA UDI
- Primary DI / UDI-DI
- 00766588160122 FDA UDI
- FDA Product Code
- LRR FDA UDIHMP FDA UDIKGX FDA UDICBP FDA UDIIMD FDA UDIEFQ FDA UDI
- GMDN Term
- Adhesive bandage FDA UDI
Classification
- Device Class
- N FDA UDI
- Regulation Number
- 878.4440 FDA UDI880.5240 FDA UDI868.5870 FDA UDI890.5710 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: First aid kit, medicatedAdhesive bandageNon-woven gauze padWound-nonadherent dressing, absorbent, non-antimicrobial
18PO - Class A OutDoor - Poly Orange by Certified Safety Manufacturing, Inc. — Class N — 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 N | Pending data |
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Manufacturer
- Manufacturer
- Certified Safety Manufacturing, Inc.
Sources (1)
- FDA UDI d4f178e8-9bbd-45bf-acf7-cbf278a4b0f8 35 fields · synced May 30, 2026