Identity
- Trade Name
- Laser Level FDA UDI
- Generic Name
- Laser patient positioning system FDA UDI
- Device Name
- LASER 27613 EXACTA W/SCREW ASSY FDA UDI
- Model / Reference
- 27613 FDA UDI
- Description
- LASER 27613 EXACTA W/SCREW ASSY FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000169886 FDA UDI
- 510(k) Number
- K201118 FDA UDI
- FDA Product Code
- GWM FDA UDI
- GMDN Term
- Laser patient positioning system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1620 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
MR Unsafe FDA UDI
Category: Laser patient positioning system
Laser Level by Medtronic PS Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Laser patient positioning system.
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- HIT Laser — C-Rad Positioning AB · Class I
- APOLLO MR3T blue line 90° — LAP GmbH Laser Applikationen · Class I
Cleared under the same submission
K201118 also covers:
- Exacta Pole Clamp with laser level — Medtronic PS Medical
- Exacta Pole Clamp with laser level — Medtronic PS Medical
- Exacta™ — Medtronic PS Medical
- Exacta™ — Medtronic PS Medical
- Exacta™ — Medtronic PS Medical
- Exacta™ — Medtronic PS Medical
- Exacta™ — Medtronic PS Medical
- Exacta™ — Medtronic PS Medical
- Exacta™ — Medtronic PS Medical
- Exacta™ — Medtronic PS Medical
- Exacta™ — Medtronic PS Medical
- Exacta™ — Medtronic PS Medical
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
- Medtronic PS Medical
Sources (1)
- FDA UDI e76ca7f6-4bcc-430e-bc87-b5b20c4e451a 35 fields · synced May 31, 2026