FDA.reportPublic FDA data

UNITY

Primary DI
10380650003918
Brand
UNITY
Company
Alcon Laboratories, Inc.
Model
00380650003911
Catalog number
8065000391
Device description
UNITY™ Tray Support Cover (Large)
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

Product Codes#

Code, Name table
CodeName
HMTDrape, Patient, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMTDrape, Patient, OphthalmicGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10380650003918PackageGS16In Commercial Distribution
00380650003911PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038065000391810380650003918
00380650003911003806500039113806500039110380650003911

GMDN Terms#

Term, Definition table
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 table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380657402601Alcon80657402602016-09-24
00380652268899ACRYSOF, IQ RESTORSND1T3SND1T3U1302017-02-24
00380658544232Clareon TruPlusRECWT3RECWT3.0752026-03-23
00380658544249Clareon TruPlusRECWT3RECWT3.0802026-03-23
00380658544256Clareon TruPlusRECWT3RECWT3.0852026-03-23
00380658544263Clareon TruPlusRECWT3RECWT3.0902026-03-23
00380658544270Clareon TruPlusRECWT3RECWT3.0952026-03-23
00380658544287Clareon TruPlusRECWT3RECWT3.1002026-03-23
00380658544294Clareon TruPlusRECWT3RECWT3.1052026-03-23
00380658544300Clareon TruPlusRECWT3RECWT3.1102026-03-23
00380658544317Clareon TruPlusRECWT3RECWT3.1152026-03-23
00380658544324Clareon TruPlusRECWT3RECWT3.1202026-03-23
00380658544331Clareon TruPlusRECWT3RECWT3.1252026-03-23
00380658544348Clareon TruPlusRECWT3RECWT3.1302026-03-23
00380658544355Clareon TruPlusRECWT3RECWT3.1352026-03-23
00380658544362Clareon TruPlusRECWT3RECWT3.1402026-03-23
00380658544379Clareon TruPlusRECWT3RECWT3.1452026-03-23
00380658544386Clareon TruPlusRECWT3RECWT3.1502026-03-23
00380658544393Clareon TruPlusRECWT3RECWT3.1552026-03-23
00380658544409Clareon TruPlusRECWT3RECWT3.1602026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50192253066638CONVERTORSCardinal Health 200, LLCHMT2025-06-18
50192253066645CONVERTORSCardinal Health 200, LLCHMT2025-06-18
50192253066669CONVERTORSCardinal Health 200, LLCHMT2025-06-18
50192253066676CONVERTORSCardinal Health 200, LLCHMT2025-06-18
50192253066683CONVERTORSCardinal Health 200, LLCHMT2025-06-18
10380650003901UNITYAlcon Laboratories, Inc.HMT2025-04-08
10380650004182UNITYAlcon Laboratories, Inc.HMT2025-04-08
10380650003888ALCONAlcon Laboratories, Inc.HMT2024-07-02
10326053120517Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.HMT2023-12-20
10326053120593Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.HMT2023-12-20
10326053120630Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.HMT2023-12-20
06931918113947AllesetGRI Medical & Electronic Technology Co., Ltd.HMT2021-02-23
06931918115354AllesetGRI Medical & Electronic Technology Co., Ltd.HMT2021-02-23
06931918118461Beaver Visitec InterGRI Medical & Electronic Technology Co., Ltd.HMT2021-02-23
06931918135444AllesetGRI Medical & Electronic Technology Co., Ltd.HMT2021-02-23
06931918139831AllesetGRI Medical & Electronic Technology Co., Ltd.HMT2021-02-23
06931918140097AllesetGRI Medical & Electronic Technology Co., Ltd.HMT2021-02-23
06931918169845Beaver Visitec InterGRI Medical & Electronic Technology Co., Ltd.HMT2021-02-23
06931918170773Beaver Visitec InterGRI Medical & Electronic Technology Co., Ltd.HMT2021-02-23
06931918176812Beaver Visitec InterGRI Medical & Electronic Technology Co., Ltd.HMT2021-02-23
06931918192737AllesetGRI Medical & Electronic Technology Co., Ltd.HMT2021-02-23
06931918199989Beaver Visitec InterGRI Medical & Electronic Technology Co., Ltd.HMT2021-02-23
26931918136087AllesetGRI Medical & Electronic Technology Co., Ltd.HMT2021-02-02
26931918176526AllesetGRI Medical & Electronic Technology Co., Ltd.HMT2021-02-02
26931918179329AllesetGRI Medical & Electronic Technology Co., Ltd.HMT2021-02-02
26931918192113AllesetGRI Medical & Electronic Technology Co., Ltd.HMT2021-02-02
26931918196760AllesetGRI Medical & Electronic Technology Co., Ltd.HMT2021-02-02
07350101640098SurgiCube drapeToul Meditech ABHMT2020-12-10
50885380169197CONVERTORSCardinal Health 200, LLCHMT2019-01-21
50885380121331CONVERTORSCardinal Health 200, LLCHMT2018-10-09