FDA.reportPublic FDA data

CONVERTORS

Primary DI
10192253066678
Brand
CONVERTORS
Company
Cardinal Health 200, LLC
Model
D1060
Catalog number
D1060
Device description
Ophthalmic Incise Drape
Published
2025-06-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
50192253066676PackageGS110In Commercial Distribution
10192253066678PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225306667650192253066676
1019225306667810192253066678

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical drapeA protective covering made of natural or synthetic materials, or both, designed to promote a clean and dry sterile field about the eye during ophthalmic surgery or refractive and general ophthalmic office procedures. The device may be used to cover the eyebrow, retract lashes or eyelids, completely occlude the eyelid, or completely cover the eye. The device is typically secured directly to the skin with a pressure-sensitive adhesive, and is typically supplied sterile. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length51Inch
Width48Inch

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253004243Monoject31143699311436992026-08-03
10192253004250Monoject31143798311437982026-08-03
10192253004304Monoject31300878313008782026-08-03
20192253050353Vistec659165912023-05-24
10192253004458Monoject85121851212026-07-31
10192253004465Monoject8513018513012026-07-31
10192253004472Monoject85131851312026-07-31
10192253004915Monoject890689062026-07-31
10192253005066Monoject89671896712026-07-31
10192253005295Monoject8990Y8990Y2026-07-31
10192253005516Monoject8535Y8535Y2026-07-31
10192253005622Monoject8970Y8970Y2026-07-31
10197106933145CARDINAL HEALTHPV42CJTMZPV42CJTMZ2026-07-31
10197106950012CARDINAL HEALTHSAN56IPIDFSAN56IPIDF2026-07-31
10198956027596CARDINAL HEALTHSCV73CAHFHSCV73CAHFH2026-07-31
10198956327603CARDINAL HEALTH26-8545D26-8545D2026-07-31
10198956342217CARDINAL HEALTHPB15LHFCLPB15LHFCL2026-07-31
10198956352315CARDINAL HEALTHPW45KFMSAPW45KFMSA2026-07-31
10198956353961CARDINAL HEALTHSNEHBNEECDSNEHBNEECD2026-07-31
10198956364998CARDINAL HEALTHSBADHHMCFDSBADHHMCFD2026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20197344179685MEDLINEMEDLINE INDUSTRIES, INC.HMT2026-02-12
10192253066630CONVERTORSCardinal Health 200, LLCHMT2025-06-18
10192253066647CONVERTORSCardinal Health 200, LLCHMT2025-06-18
10192253066661CONVERTORSCardinal Health 200, LLCHMT2025-06-18
10192253066685CONVERTORSCardinal Health 200, LLCHMT2025-06-18
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
00380650003904UNITYAlcon Laboratories, Inc.HMT2025-04-08
00380650003911UNITYAlcon Laboratories, Inc.HMT2025-04-08
00380650004185UNITYAlcon Laboratories, Inc.HMT2025-04-08
10380650003901UNITYAlcon Laboratories, Inc.HMT2025-04-08
10380650003918UNITYAlcon Laboratories, Inc.HMT2025-04-08
10380650004182UNITYAlcon Laboratories, Inc.HMT2025-04-08
00380650003881ALCONAlcon Laboratories, Inc.HMT2024-07-02
10380650003888ALCONAlcon Laboratories, Inc.HMT2024-07-02
00326053120510Regard™Resource Optimization & Innovation, L.L.C.HMT2023-12-20
00326053120596Regard™Resource Optimization & Innovation, L.L.C.HMT2023-12-20
00326053120633Regard™Resource Optimization & Innovation, L.L.C.HMT2023-12-20
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