Precision Mixing & Delivery System

FDA UDI

Class II (US FDA UDI)

by Zimmer, Inc.

Identity

Trade Name: Precision Mixing & Delivery System FDA UDI
Generic Name: Bone graft delivery kit FDA UDI
Model / Reference: 76-6047 FDA UDI

Identifiers

Primary DI / UDI-DI: 00889024205581 FDA UDI
510(k) Number: K141245 FDA UDI
FDA Product Code: FMF FDA UDI
GMDN Term: Bone graft delivery kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5860 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Bone graft delivery kit

Precision Mixing & Delivery System by Zimmer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Bone graft delivery kit.

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Arthrex® — Arthrex, Inc. · Class I
SCP® — Zimmer Knee Creations, Inc. · Class I

Cleared under the same submission

K141245 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Zimmer, Inc.

Sources (1)

FDA UDI 01b1a68e-74d8-4a55-9fd0-09932fd8a696 36 fields · synced May 30, 2026