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Master Holder

EUDAMEDFDA UDI

Class I (EU MDR)

Ref ACC-300Model ACC-101

by Medical Microinstruments, Inc.

Identity

Trade Name
Master Holder EUDAMED
Symani Accessories Master Holder FDA UDI
Generic Name
Medical equipment/instrument drape, single-use FDA UDI
Device Name
Symani Accessories EUDAMED
A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device. FDA UDI
Model / Reference
ACC-101 EUDAMED
ACC-300 EUDAMEDFDA UDI
Description
A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device. FDA UDI

Identifiers

Primary DI / UDI-DI
08055713175035 EUDAMEDFDA UDI
Basic UDI-DI
805571317SymACTT EUDAMED
FDA Product Code
SAQ FDA UDI
EMDN Code
V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
GMDN Term
Medical equipment/instrument drape, single-use FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
878.4963 FDA UDI
Market of Registration
Italy EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Device sterilization/disinfection container, reusable

Master Holder by Medical Microinstruments, Inc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Device sterilization/disinfection container, reusable.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union No Longer Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medical Microinstruments, Inc.
EUDAMED SRN
IT-MF-000013306

Sources (2)

  • EUDAMED bf6b6667-4005-4c4a-a47d-b720d27c8293 61 fields · synced Jul 12, 2026
  • FDA UDI 092b9dc2-5328-4576-90c2-e0754124d9f8 33 fields · synced May 30, 2026