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7D Surgical Registration Frame

FDA UDI

Class II (US FDA UDI)

by 7D Surgical ULC

Identity

Trade Name
7D Surgical Registration Frame FDA UDI
Generic Name
Imaging lesion localization marker, external, single-use FDA UDI
Model / Reference
11-0066 FDA UDI

Identifiers

Primary DI / UDI-DI
00628341520553 FDA UDI
FDA Product Code
OLO FDA UDI
GMDN Term
Imaging lesion localization marker, external, single-use 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

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Imaging lesion localization marker, external, single-use

7D Surgical Registration Frame by 7D Surgical ULC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Imaging lesion localization marker, external, single-use.

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 d633ab2c-11f4-4b73-bdc5-e020c1024ef8 32 fields · synced Jun 8, 2026