Identity
- Trade Name
- SPOTLIGHT FDA UDI
- Generic Name
- Laparoscopic multi-instrument access port, single-use FDA UDI
- Device Name
- SPOTLIGHT ACCESS SYSTEM NON-ILLUMINATED STRAIGHT PORT 18 x 60mm FDA UDI
- Model / Reference
- 282918061 FDA UDI
- Description
- SPOTLIGHT ACCESS SYSTEM NON-ILLUMINATED STRAIGHT PORT 18 x 60mm FDA UDI
Identifiers
- Catalog Number
- 282918061 FDA UDI
- Primary DI / UDI-DI
- 10705034206400 FDA UDI
- 510(k) Number
- K062814 FDA UDI
- FDA Product Code
- GZT FDA UDI
- GMDN Term
- Laparoscopic multi-instrument access port, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4800 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Laparoscopic multi-instrument access port, single-use
Spotlight by Depuy Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K062814 also covers:
- SPOTLIGHT — Depuy Spine, Inc.
- SPOTLIGHT — Depuy Spine, Inc.
- SPOTLIGHT — Depuy Spine, Inc.
- SPOTLIGHT — Depuy Spine, Inc.
- SPOTLIGHT — Depuy Spine, Inc.
- SPOTLIGHT — Depuy Spine, Inc.
- SPOTLIGHT — Depuy Spine, Inc.
- SPOTLIGHT — Depuy Spine, Inc.
- SPOTLIGHT — Depuy Spine, Inc.
- SPOTLIGHT — Depuy Spine, Inc.
- SPOTLIGHT — Depuy Spine, Inc.
- SPOTLIGHT — Depuy Spine, Inc.
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
- Depuy Spine, Inc.
Sources (1)
- FDA UDI 8c7b35d5-b0aa-4cc3-b1ee-63ad57e0f48c 36 fields · synced May 30, 2026