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Ultimate Vit Enhancer™

FDA UDI

Class II (US FDA UDI)

by Medical Instrument Development Laboratories, Inc.

Identity

Trade Name
Ultimate Vit Enhancer™ FDA UDI
Generic Name
Vitrectomy system FDA UDI
Device Name
Ultimate Vit Enhancer™, 8000cpm capable FDA UDI
Model / Reference
6400 FDA UDI
Description
Ultimate Vit Enhancer™, 8000cpm capable FDA UDI

Identifiers

Catalog Number
6400 FDA UDI
Primary DI / UDI-DI
00812480010994 FDA UDI
510(k) Number
K102222 FDA UDI
FDA Product Code
HQE FDA UDI
GMDN Term
Vitrectomy system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.4150 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Depth — 11.25 Inch FDA UDI
Width — 6.75 Inch FDA UDI
Height — 11 Inch FDA UDI

Category: Vitrectomy system

Ultimate Vit Enhancer™ by Medical Instrument Development Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vitrectomy system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medical Instrument Development Laboratories, Inc.

Sources (1)

  • FDA UDI 6d8b7987-cb7f-4e27-a27d-9adccf2a7432 38 fields · synced Jun 8, 2026