FDA.reportPublic FDA data

CONVERTORS

Primary DI
50885380151499
Brand
CONVERTORS
Company
Cardinal Health 200, LLC
Model
42098MNS
Catalog number
42098MNS
Device description
OPHTHALMIC DRAPE BULK NON-STERILE
Published
2017-06-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
HMTDrape, patient, ophthalmic
KXXADHESIVE, DENTURE, KARAYA AND ETHYLENE-OXIDE HOMOPOLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMTDrape, Patient, OphthalmicGeneral, Plastic Surgery2
KXXAdhesive, Denture, Karaya And Ethylene-Oxide HomopolymerDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885380151499PrimaryGS10
10885380151491Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538015149950885380151499
1088538015149110885380151491

GMDN Terms#

Term, Definition table
TermDefinition
Patient surgical drape, single-use, non-sterileA non-sterile, noninvasive flat sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to isolate a specific anatomical site (e.g., site of surgical incision) from potential contamination (e.g., microbial, substance). The device may also be used to protect a patient from heat/flame during a surgical procedure, however it is not designed with specific heat-reflective or laser resistant materials. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
961027315
Device count
9
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

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
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
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10326053120630Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.HMT2023-12-20
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