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Extremity Care

FDA UDI

Class I (US FDA UDI)

by Extremity Care, Llc

Identity

Trade Name
Extremity Care FDA UDI
Generic Name
Tissue injection cannula FDA UDI
Device Name
Cannula Kit Spatula w/Scalpel Kit Includes: Primary DI: 00850003042275 Version: ALC225 Device Description:Spatula Cannula Distal Tip for ID:2.5mm, OD:3.0mm, Spatula & Cobra Cannula Tube ID:2.5mm, OD:3.0mm Primary DI: 00850003042299 Version: ATL400 Device Description: Thumb Scalpel (#11) FDA UDI
Model / Reference
ALC200S FDA UDI
Description
Cannula Kit Spatula w/Scalpel Kit Includes: Primary DI: 00850003042275 Version: ALC225 Device Description:Spatula Cannula Distal Tip for ID:2.5mm, OD:3.0mm, Spatula & Cobra Cannula Tube ID:2.5mm, OD:3.0mm Primary DI: 00850003042299 Version: ATL400 Device Description: Thumb Scalpel (#11) FDA UDI

Identifiers

Primary DI / UDI-DI
00850003042244 FDA UDI
FDA Product Code
GEA FDA UDI
GES FDA UDI
GMDN Term
Tissue injection cannula FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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: Manual scalpel blade, single-useTissue injection cannula

Extremity Care by Extremity Care, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tissue injection cannula.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Extremity Care, Llc

Sources (1)

  • FDA UDI ade92419-ea2f-49e8-ba12-94410bc42bf2 34 fields · synced May 31, 2026