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Agili-C Mini Disposable Toolset

FDA UDI

Class II (US FDA UDI)

by Cartiheal (2009) Ltd

Identity

Trade Name
Agili-C Mini Disposable Toolset FDA UDI
Generic Name
Orthopaedic inorganic implant inserter/extractor, single-use FDA UDI
Device Name
Agili-C Mini Disposable Toolset FDA UDI
Model / Reference
MINI-DS FDA UDI
Description
Agili-C Mini Disposable Toolset FDA UDI

Identifiers

Catalog Number
MINI-DS FDA UDI
Primary DI / UDI-DI
07290019087045 FDA UDI
FDA Product Code
QBO FDA UDI
GMDN Term
Orthopaedic inorganic implant inserter/extractor, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.4505 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Orthopaedic inorganic implant inserter/extractor, single-use

Agili-C Mini Disposable Toolset by Cartiheal (2009) Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic inorganic implant inserter/extractor, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI bf227415-8023-4be8-9af8-9705b906135a 35 fields · synced Jun 8, 2026