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Optics One

FDA UDI

Class II (US FDA UDI)

by Medical Technique, Inc.

Identity

Trade Name
OPTICS ONE FDA UDI
Generic Name
Instrument/equipment drape, single-use, sterile FDA UDI
Device Name
Bandbag Latex Free Band 36 x 20 FDA UDI
Model / Reference
BB3620R FDA UDI
Description
Bandbag Latex Free Band 36 x 20 FDA UDI

Identifiers

Catalog Number
BB3620R FDA UDI
Primary DI / UDI-DI
00815384022728 FDA UDI
FDA Product Code
KKX FDA UDI
GMDN Term
Instrument/equipment drape, single-use, sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4370 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

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

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: Instrument/equipment drape, single-use, sterile

Optics One by Medical Technique, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Instrument/equipment drape, single-use, sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medical Technique, Inc.

Sources (1)

  • FDA UDI be61097b-9425-4f82-8d6a-dc6f923e7148 35 fields · synced May 31, 2026