Identity
- Trade Name
- Orthopli FDA UDI
- Generic Name
- Sterilization packaging, reusable FDA UDI
- Model / Reference
- OP10 FDA UDI
Identifiers
- Primary DI / UDI-DI
- D917OP100 FDA UDI
- 510(k) Number
- K101653 FDA UDI
- FDA Product Code
- KCT FDA UDI
- GMDN Term
- Sterilization packaging, reusable 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
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Sterilization packaging, reusable
Orthopli by Orthopli Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sterilization packaging, reusable.
- E-Z Jett Cassette — ZIRC DENTAL PRODUCTS, INC. · Class I
- Encompass — Encompass Group, L.L.C. · Class II
- ComPel Single Wrap — STANDARD TEXTILE CO., INC. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Brasseler USA — Peter Brasseler Holdings, LLC · Class II
- Brasseler USA — Peter Brasseler Holdings, LLC · Class II
- E-Z Jett Cassette — ZIRC DENTAL PRODUCTS, INC. · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class II
Cleared under the same submission
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Orthopli Corp.
Sources (1)
- FDA UDI 5601499b-1510-4530-a3d6-0fba00588d53 33 fields · synced May 30, 2026