FDA.reportPublic FDA data

Custom Healthcare Systems Inc.

Primary DI
20811870030684
Brand
Custom Healthcare Systems Inc.
Company
CUSTOM HEALTHCARE SYSTEMS, INC.
Model
S6-4050
Published
2018-07-30
Public version status
Update
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
OJKEye Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJKEye TrayOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20811870030684PackageGS140In Commercial Distribution
00811870030680PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081187003068420811870030684
00811870030680008118700306808118700306800811870030680

GMDN Terms#

Term, Definition table
TermDefinition
Lacrimal intubation setA collection of devices intended to be used to maintain patency of the nasolacrimal system typically for treating/preventing pathologies of the tear drainage system (e.g., post-chemotherapy stenosis) or after dacryocystorhinostomy (DCR). It consists of a long and flexible bicanalicular or monocanalicular tube (e.g., Crawford type) inserted through the lacrimal puncta into the canaliculi, lacrimal sac, and/or nasolacrimal duct; devices to assist the intubation procedure are typically provided preassembled to the tube (e.g., cannula, probes, bougies, introducer, stylet). The tube is typically left in place long-term before removal. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
175254820
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20811870035757Custom Healthcare Systems of VA, LLCCPT56102021-08-11
20811870035962Custom Healthcare Systems of VA, LLCCPT55002021-08-11
20811870035702Custom Healthcare Systems of VA, LLCA2081V-62021-08-09
20811870035740Custom Healthcare Systems of VA, LLCB9-16350D2021-08-09
20811870035689Custom Healthcare Systems of VA, LLCOSC-200612021-07-30
20811870035665Custom Healthcare Systems of VA, LLCDT-193432021-07-15
20811870035672Custom Healthcare Systems of VA, LLCB9-9754A2021-07-15
20811870035634Custom Healthcare Systems of VA, LLCDT-19714 v22021-07-12
20811870035580Custom Healthcare Systems of VA, LLCL4000-200272021-07-06
20811870035566Custom Healthcare Systems of VA, LLCKM-19796-12021-06-29
20811870035535Custom Healthcare Systems of VA, LLCB9-200082021-06-18
20811870035559Custom Healthcare Systems of VA, LLCCLT-199142021-06-18
20811870035498Custom Healthcare Systems of VA, LLC36774662021-06-11
20811870035474Custom Healthcare Systems of VA, LLCL1000-199362021-06-10
20811870035528Custom Healthcare Systems of VA, LLCL1000-200002021-06-10
20811870035450Custom Healthcare Systems of VA, LLCMWM-18937-022021-06-04
20811870035443Custom Healthcare Systems of VA, LLCZZ-14112021-05-24
20811870035306Custom Healthcare Systems of VA, LLCZZ-14102021-05-07
20811870035382Custom Healthcare Systems of VA, LLCZZ-14132021-05-07
20811870035399Custom Healthcare Systems of VA, LLCZZ-14122021-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956562905CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-26
10198956624528CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-26
B098AMS200500Aligned Medical SolutionsAligned Medical SolutionsOJK2026-10-26
10198956559820CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-23
10198956592872CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-23
10198956604308CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-23
10198956612464CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-23
10198956613386CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-23
10198956613454CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-23
10198956390799CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-19
10198956584129CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-19
10198956598812CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-19
10198956611290CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-19
10198956613195CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-19
10198956604735CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-15
10198956564237CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-13
10198956421240CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956553361CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956562912CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956567412CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956567634CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956568082CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956573505CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956579736CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956583887CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956586734CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956589032CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956597563CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956604469CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956463530CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-06