FDA.reportPublic FDA data

CustomEyes®

Primary DI
30886158022290
Brand
CustomEyes®
Company
Beaver-Visitec International, Inc.
Model
58001127
Catalog number
58001127
Device description
CUSTOMEYES KIT 58001127 (1/EA)
Published
2024-06-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDDKit, surgical instrument, disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDDKit, Surgical Instrument, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30886158022290PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088615802229030886158022290

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(866)906-8080customersupport@bvimedical.com

Regulatory Flags#

DUNS number
001406024
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30886158015292Parasol®A14-200A14-2002022-02-01
30886158015315Parasol®A14-2022022-02-01
30886158015322PARASOL®A14-203A14-2032022-02-02
30886158015414Parasol®A14-202BN2022-02-01
30886158015421PARASOL®A14-203BNA14-203BN2022-02-02
30886158015544PARASOL®A14-203QLA14-203QL2022-02-02
30886158012550Ultracell40400-82016-09-19
30886158012604UltracellNS40400-82016-09-19
30886158012611UltracellS40400-82016-09-19
30886158012628Ultracell408102016-09-19
30886158012642Ultracell408002016-09-20
30886158012659Ultracell40405-82016-09-19
30886158013205UltraClean™408152016-09-19
30886158014714UltracellBS40400-82016-09-19
30886158016015Endo Optiks®OME20002016-09-30
30886158002254Visitec®5810195810192024-06-27
30886158002650Visitec®5817085817082024-06-06
30886158010358Visitec000860100086012024-06-06
00886158002321Visiwipe5810475810472025-09-10
00886158106586BVIELP19CU5ELP19CU52025-09-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850074437048OftalOnePack, Oftal-OneOFTAL-ONE INC.KDD2026-02-26
00850074437109OftalOnePack, Oftal-OneOFTAL-ONE INC.KDD2026-02-26
00850074437116OftalOnePack, Oftal-OneOFTAL-ONE INC.KDD2026-02-26
50885380211193Aero-MedAERO-MED, LLCKDD2026-02-13
10653160392248Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2026-02-11
07901125600584Disposable Hip InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDAKDD2026-01-29
07901125600591Disposable Hip InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDAKDD2026-01-29
07901125600607Disposable Hip InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDAKDD2026-01-29
07901125600614Disposable Hip InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDAKDD2026-01-29
50749756397808DeRoyalDEROYAL INDUSTRIES, INC.KDD2026-01-22
10653160391302MedlineMEDLINE INDUSTRIES, INC.KDD2026-01-15
50885380206656Aero-MedAERO-MED, LLCKDD2026-01-15
00887868572524ToggleLoc™ WasherLoc™Biomet Orthopedics, LLCKDD2026-01-14
00850074437123OftalOnePackOFTAL-ONE INC.KDD2026-01-05
10653160390671Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2025-12-04
08800071700517TIGER GUARD PLUSKims Med Co.,Ltd.KDD2025-11-28
40198459450649MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459453510MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459454647MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459455231MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459456238MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459459697MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459459765MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459459888MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459460044MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459471767MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459473846MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459474669MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18
40198459476106MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDD2025-08-18