Identity
- Trade Name
- Surgical Direct FDA UDI
- Generic Name
- Orthopaedic joint/limb rongeur FDA UDI
- Device Name
- 1.6mm Basket Punch, Upbiter, Curved Left, Loop Handle FDA UDI
- Model / Reference
- SD48-2042LH FDA UDI
- Description
- 1.6mm Basket Punch, Upbiter, Curved Left, Loop Handle FDA UDI
Identifiers
- Catalog Number
- SD48-2042LH FDA UDI
- Primary DI / UDI-DI
- B382SD482042LH0 FDA UDI
- 510(k) Number
- K181173 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Orthopaedic joint/limb rongeur FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic joint/limb rongeur
Surgical Direct by Surgical Direct, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic joint/limb rongeur.
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- Hayden Medical — Hayden Medical Inc · Class I
- MICRO FRIEDMAN RONGEUR — SONTEC INSTRUMENTS, INC. · Class I
- Sklar® — Sklar Corporation · Class I
- PILLING — TELEFLEX INCORPORATED · Class I
Cleared under the same submission
K181173 also covers:
- Millennium — AVALIGN TECHNOLOGIES, Inc.
- Millennium — AVALIGN TECHNOLOGIES, Inc.
- Millennium — AVALIGN TECHNOLOGIES, Inc.
- Millennium — AVALIGN TECHNOLOGIES, Inc.
- Millennium — AVALIGN TECHNOLOGIES, Inc.
- Millennium — AVALIGN TECHNOLOGIES, Inc.
- Millennium — AVALIGN TECHNOLOGIES, Inc.
- ELMED — ELMED INCORPORATED
- ELMED — ELMED INCORPORATED
- ELMED — ELMED INCORPORATED
- ELMED — ELMED INCORPORATED
- ELMED — ELMED INCORPORATED
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
- Surgical Direct, Inc.
Sources (1)
- FDA UDI 397dfb58-62f3-4281-82e3-107f9f7e35b2 36 fields · synced Jun 6, 2026