Identity
- Trade Name
- 3D Dental-Kangaroo FDA UDI
- Generic Name
- Sterilization packaging, single-use FDA UDI
- Device Name
- Self-Seal Sterilization Pouches 100/Bx 7.5"x13" FDA UDI
- Model / Reference
- SP7X13 FDA UDI
- Description
- Self-Seal Sterilization Pouches 100/Bx 7.5"x13" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817169021216 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Sterilization packaging, single-use
3D Dental-Kangaroo by 3d Dental Designs And Development, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class II
- Plasdent — PLASDENT CORP. · Class II
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
- 3d Dental Designs And Development, Llc
Sources (1)
- FDA UDI 59a3d4dd-bcbd-48f4-a683-c95da3cffcc9 33 fields · synced Jun 8, 2026