FDA.reportPublic FDA data

CONVERTORS

Primary DI
50192253066645
Brand
CONVERTORS
Company
Cardinal Health 200, LLC
Model
D1025
Catalog number
D1025
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
Rx
false
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
50192253066645PackageGS110In Commercial Distribution
10192253066647PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225306664550192253066645
1019225306664710192253066647

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
10192253004649Monoject8602RC8602RC2026-07-09
10192253004656Monoject8605RC8605RC2026-07-09
10192253004663Monoject8607RC8607RC2026-07-09
10192253004700Monoject8617RC8617RC2026-07-09
10192253051575Precision2650SA2650SA2026-07-09
10197106896327CARDINAL HEALTHSNENU0868BSNENU0868B2026-07-09
10198956074668CARDINAL HEALTHSBA37OTMOFSBA37OTMOF2026-07-09
10198956119260CARDINAL HEALTHSBA69MPSUBSBA69MPSUB2026-07-09
10198956119437CARDINAL HEALTHPVVMVPBLGPVVMVPBLG2026-07-09
10198956255586CARDINAL HEALTHSOP53SAPTHSOP53SAPTH2026-07-09
10198956268272CARDINAL HEALTHSMA54CSWMMSMA54CSWMM2026-07-09
10198956286719CARDINAL HEALTHSOT11BR10MSOT11BR10M2026-07-09
10198956307308CARDINAL HEALTHSAN43ADSWOSAN43ADSWO2026-07-09
10198956313576CARDINAL HEALTHSMA69BTDNBSMA69BTDNB2026-07-09
10198956333888CARDINAL HEALTHPBCGLSARGPBCGLSARG2026-07-09
10198956334373CARDINAL HEALTHSNECGBPNODSNECGBPNOD2026-07-09
10198956339132CARDINAL HEALTHSEYHDCAGWHSEYHDCAGWH2026-07-09
10198956345942CARDINAL HEALTHSANOCIRHTBSANOCIRHTB2026-07-09
10198956349834CARDINAL HEALTHSAN73PLCHMSAN73PLCHM2026-07-09
10198956360358CARDINAL HEALTHSCV73VPBHDSCV73VPBHD2026-07-09

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
10192253066678CONVERTORSCardinal Health 200, LLCHMT2025-06-18
10192253066685CONVERTORSCardinal Health 200, LLCHMT2025-06-18
50192253066638CONVERTORSCardinal 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