Identity
- Trade Name
- Reliance Fusion Light FDA UDI
- Generic Name
- Sterilization packaging, single-use FDA UDI
- Device Name
- WLJ1HZ083B, Sterilization Wrap, Reliance Fusion Light, Blue and green bonded alternating sheets, 15 x 15 inches [] 480 applications per case. As used, blue sheet is outer layer. FDA UDI
- Model / Reference
- FL01515 FDA UDI
- Description
- WLJ1HZ083B, Sterilization Wrap, Reliance Fusion Light, Blue and green bonded alternating sheets, 15 x 15 inches [] 480 applications per case. As used, blue sheet is outer layer. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841982101558 FDA UDI
- 510(k) Number
- K230137 FDA UDI
- FDA Product Code
- FRG FDA UDI
- GMDN Term
- Sterilization packaging, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6850 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Sterilization packaging, single-use
Reliance Fusion Light by Ahlstrom Nonwovens Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K230137 also covers:
- Reliance Fusion Heavy — AHLSTROM NONWOVENS LLC
- Reliance Fusion Heavy — AHLSTROM NONWOVENS LLC
- Reliance Fusion Heavy — AHLSTROM NONWOVENS LLC
- Reliance Fusion Heavy — AHLSTROM NONWOVENS LLC
- Reliance Fusion Heavy — AHLSTROM NONWOVENS LLC
- Reliance Fusion Heavy — AHLSTROM NONWOVENS LLC
- Reliance Fusion Light — AHLSTROM NONWOVENS LLC
- Reliance Fusion Light — AHLSTROM NONWOVENS LLC
- Reliance Fusion Light — AHLSTROM NONWOVENS LLC
- Reliance Fusion Light — AHLSTROM NONWOVENS LLC
- Reliance Fusion Light — AHLSTROM NONWOVENS LLC
- Reliance Fusion Light — AHLSTROM NONWOVENS LLC
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
- Ahlstrom Nonwovens Llc
Sources (1)
- FDA UDI 4d1e8a42-da44-42e6-b644-f731eb1b842f 35 fields · synced May 30, 2026