FDA.report

UNITY

Primary DI
10380650004182
Brand
UNITY
Company
Alcon Laboratories, Inc.
Model
00380650004185
Catalog number
8065000418
Device description
UNITY™ Tray Support Cover (Small)
Published
2025-04-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
HMTDrape, Patient, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HMTDrape, Patient, OphthalmicGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10380650004182PackageGS16In Commercial Distribution
00380650004185PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1038065000418210380650004182
00380650004185003806500041853806500041850380650004185

GMDN Terms

TermDefinition
Medical equipment/instrument drape, single-useA 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008018525
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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