← Back to catalogue

Mitek Sports Medicine

FDA UDI

Class I (US FDA UDI)

by Micromedics, Inc.

Identity

Trade Name
MITEK SPORTS MEDICINE FDA UDI
Generic Name
Irrigation syringe FDA UDI
Device Name
MITEK SPORTS MEDICINE RATIO APPLICATOR ASSEMBLY 11:1 FDA UDI
Model / Reference
278011 FDA UDI
Description
MITEK SPORTS MEDICINE RATIO APPLICATOR ASSEMBLY 11:1 FDA UDI

Identifiers

Primary DI / UDI-DI
00815634020009 FDA UDI
FDA Product Code
KYZ FDA UDI
GMDN Term
Irrigation syringe FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6960 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Irrigation syringe

Mitek Sports Medicine by Micromedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Irrigation syringe.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Micromedics, Inc.

Sources (1)

  • FDA UDI 9ab53a69-a233-467a-ac1a-1aaf6d83abd7 33 fields · synced May 31, 2026