FDA.reportPublic FDA data

Manus Medical, LLC

Primary DI
20811870037928
Brand
Manus Medical, LLC
Company
Manus Medical, LLC
Model
A2081V-7
Device description
THE EYE INSTITUTE OF UTAH LASIK PACK
Published
2024-02-02
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
OJKEye Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJKEye TrayOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20811870037928PackageGS130In Commercial Distribution
00811870037924PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081187003792820811870037928
00811870037924008118700379248118700379240811870037924

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical procedure kit, non-medicated, single-useA collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
800604196
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
00811870037979Manus Medical, LLCZZ-0683-12024-02-06
00811870033216Custom Healthcare Systems Inc.UNC-179142018-07-25
00811870035555Custom Healthcare Systems of VA, LLCCLT-199142021-06-18
00811870030703Custom Healthcare Systems Inc.VBS-18520C2018-10-19
00811870032943CUSTOM HEALTHCARE SYSTEMS, INCDT-0520192019-06-03
00811870034411Custom Healthcare Systems Inc.VBS-18520B2018-10-19
00811870035036Custom Healthcare Systems, Inc.DT-197142020-04-09
00811870035166Custom Healthcare Systems, Inc.CUS1365-022020-07-28
00811870035630Custom Healthcare Systems of VA, LLCDT-19714 v22021-07-12
00811870035661Custom Healthcare Systems of VA, LLCDT-193432021-07-15
00811870035883Custom Healthcare Systems Inc.VBS-191082019-03-07
00811870035890Custom Healthcare Systems Inc.11168030152019-03-07
00811870037863Manus Medical, LLCEMLP-20375-12023-12-20
00811870037986Manus Medical, LLCUNC-9800-02024-02-07
20811870037980Manus Medical, LLCUNC-9800-02024-02-07
20811870037973Manus Medical, LLCZZ-0683-12024-02-06
00811870037887Manus Medical, LLCLPGM-0012024-02-02
00811870037900Manus Medical, LLCLPGM-002-12024-02-02
00811870037917Manus Medical, LLCMMCUS11732024-02-02
00811870037924Manus Medical, LLCA2081V-72024-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B098AMS14577A0Aligned Medical SolutionsAligned Medical SolutionsOJK2026-07-22
10198956363960CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
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B098AMS192180Aligned Medical SolutionsAligned Medical SolutionsOJK2026-07-19
10198956382930CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-16
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10198956519626CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-16
10198956529441CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-16
10198956530584CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-16
B098AMS193400Aligned Medical SolutionsAligned Medical SolutionsOJK2026-07-12
10198956339132CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956391949CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09