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Envision 3d: Light Handle

FDA UDI

Class II (US FDA UDI)

by 7D Surgical ULC

Identity

Trade Name
ENVISION 3D: LIGHT HANDLE FDA UDI
Generic Name
Optical surgical navigation device tracking system workstation, mobile FDA UDI
Model / Reference
11-0005 FDA UDI

Identifiers

Primary DI / UDI-DI
00627843746669 FDA UDI
FDA Product Code
OLO FDA UDI
GMDN Term
Optical surgical navigation device tracking system workstation, mobile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4560 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Optical surgical navigation device tracking system workstation, mobile

Envision 3d: Light Handle by 7D Surgical ULC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Optical surgical navigation device tracking system workstation, mobile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
7D Surgical ULC

Sources (1)

  • FDA UDI 4af14f54-239f-4e19-8b44-5177e8493815 32 fields · synced Jun 1, 2026