Identity
- Trade Name
- Exacta™ FDA UDI
- Generic Name
- Laser patient positioning system FDA UDI
- Device Name
- CLAMP 46715 EXACTA PL NEG 25CM W/LSR FDA UDI
- Model / Reference
- 46715 FDA UDI
- Description
- CLAMP 46715 EXACTA PL NEG 25CM W/LSR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00681490535649 FDA UDI
- 510(k) Number
- K983799 FDA UDI
- FDA Product Code
- GWM FDA UDIJXG FDA UDI
- GMDN Term
- Laser patient positioning system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1620 FDA UDI882.5550 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
Exacta™ by Medtronic PS Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Laser patient positioning system.
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- Laser Positioning System — Klarity Medical & Equipment（GZ） Co.,Ltd. · Class I
- DORADO — L A P GMBH LASER APPLIKATIONEN · Class I
- HIT Laser — C-Rad Positioning AB · Class I
- APOLLO MR3T blue line 90° — LAP GmbH Laser Applikationen · Class I
Cleared under the same submission
K983799 also covers:
- Clear-Site® — Medtronic PS Medical
- EDM — Medtronic PS Medical
- 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
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 9c9b2eec-851d-487f-8991-f2f231c19412 36 fields · synced Jun 8, 2026