Identity
- Trade Name
- Retractor FDA UDI
- Generic Name
- Hand-held surgical retractor, reusable FDA UDI
- Device Name
- Retractor FDA UDI
- Model / Reference
- RT00 FDA UDI
- Description
- Retractor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810054091103 FDA UDI
- 510(k) Number
- K191118 FDA UDI
- FDA Product Code
- HRS FDA UDIHWC FDA UDI
- GMDN Term
- Hand-held surgical retractor, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI888.3040 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
Yes
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Hand-held surgical retractor, reusable
Retractor by Avanti Orthopaedics Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K191118 also covers:
- Aiming Guide, 2.0mm — AVANTI ORTHOPAEDICS LLC
- Assembled Screw Driver, 1.7mm — AVANTI ORTHOPAEDICS LLC
- Avanti Cannulated Countersink, 2.7mm — AVANTI ORTHOPAEDICS LLC
- Cannulated Screw, 2.7mm x 14mm Long — AVANTI ORTHOPAEDICS LLC
- Cannulated Screw, 2.7mm x 18mm Long — AVANTI ORTHOPAEDICS LLC
- Cannulated Screw, 2.7mm x 20mm Long — AVANTI ORTHOPAEDICS LLC
- Cannulated Screw, 2.7mm x 22mm Long — AVANTI ORTHOPAEDICS LLC
- Cannulated Screw, 2.7mm x 26mm Long — AVANTI ORTHOPAEDICS LLC
- Cannulated Screw, 2.7mm x 28mm Long — AVANTI ORTHOPAEDICS LLC
- Cannulated Screw, 2.7mm x 32mm Long — AVANTI ORTHOPAEDICS LLC
- Cannulated Screw, 2.7mm x 34mm Long — AVANTI ORTHOPAEDICS LLC
- Cannulated Screw, 2.7mm x 36mm Long — AVANTI ORTHOPAEDICS 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
- Avanti Orthopaedics Llc
Sources (1)
- FDA UDI 14a0b943-41f8-4110-999c-7c7fa82084b2 35 fields · synced May 30, 2026