miLOOP reusable

Primary DI
30850005541074
Brand
miLOOP reusable
Company
Carl Zeiss Meditec, Cataract Technology, Inc.
Model
FG-50896
Device description
Ophthalmic Instrument. Lens Fragmentation Device.
Published
2024-08-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNQHook, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNQHook, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30850005541074PackageGS14In Commercial Distribution
00850005541073PrimaryGS10
10850005541070Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3085000554107430850005541074
00850005541073008500055410738500055410730850005541073
1085000554107010850005541070

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic soft-tissue manipulation forceps, probe-like, reusableA hand-held manual instrument designed to grasp and manipulate intraocular tissues during ophthalmic surgery (e.g., anterior segment surgery, vitreo-retinal procedures, iridectomy, capsulorhexis). It has a probe-like design with a proximal handle (typically cylindrical), a thin cannula-like shaft, and small grasping blades that protrude from the distal end of the shaft. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
775-473-1014qualitycti.med.us@zeiss.com

Regulatory Flags#

DUNS number
080125056
Device count
2
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
true
Expiration date on label
false
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
00850005541080MICOR Auto I/AFG-518202025-08-19
00850005541073miLOOP reusableFG-508962024-08-30
00860000122306miLOOP1042019-02-12
00850005541042MICOR VitrectorFG-508292023-07-28
00860000122368MICOR extractorFG-506212021-01-29
00860000122375MICOR driveFG-506312021-01-29

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