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Sil-serter™

FDA UDI

Class II (US FDA UDI)

by Medtronic Minimed, Inc.

Identity

Trade Name
Sil-serter™ FDA UDI
Generic Name
Injector reset device FDA UDI
Device Name
LANCET DEVICE MMT-385 SILSRTR EA 21L SMC FDA UDI
Model / Reference
MMT-385 FDA UDI
Description
LANCET DEVICE MMT-385 SILSRTR EA 21L SMC FDA UDI

Identifiers

Primary DI / UDI-DI
00643169705920 FDA UDI
510(k) Number
K010377 FDA UDI
FDA Product Code
KZH FDA UDI
GMDN Term
Injector reset device FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.6920 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Injector reset device

Sil-serter™ by Medtronic Minimed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Injector reset device.

Cleared under the same submission

K010377 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic Minimed, Inc.

Sources (1)

  • FDA UDI ec286c58-15d3-46d2-bcf2-0ce29e51058a 35 fields · synced May 31, 2026