FDA.reportPublic FDA data

INTRECTOR®

Primary DI
00856222004759
Brand
INTRECTOR®
Company
INSIGHT INSTRUMENTS, INC.
Model
71200
Catalog number
71200
Device description
INTRECTOR® Portable Vitrectomy System including REF: 71102 Power Unit & REF: 71101 Handpiece
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856222004759PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856222004759008562220047598562220047590856222004759

GMDN Terms#

Term, Definition table
TermDefinition
Vitrectomy systemAn assembly of ophthalmic devices intended to deliver energy (e.g., ultrasonic, piezoelectric, pneumatic) through a dedicated hand-held instrument, which converts the energy into an oscillating-cutting action to remove (nibble away) vitreous humour (the jelly-like substance that fills the centre of the eye) during ophthalmic surgery. This system will typically consist of a generator to provide the energy, an infusion and suction system to supply replacement fluid and remove debris, a cutting handpiece and cables, and a foot control. This assembly is typically used to treat diabetic vitreous haemorrhage, retinal detachment, epiretinal membrane, and macular hole.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(772) 219-9393CustomerService@InsightInstruments.com

Regulatory Flags#

DUNS number
828348391
Device count
1
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856222004834SUPER VIEW® Pack for ZEISS RESIGHT®TS-RP-7001402242016-09-23
00856222004841SUPER VIEW® Pack for ZEISS RESIGHT®TS-RP-7002402252016-09-23
00856222004049SUPER VIEW® Disposable Lens Set for RESIGHT®40219402192016-09-23
00856222004063SUPER VIEW® Disposable Lens Set for ZEISS RESIGHT®TS-ZR-LS402262016-09-23
00856222004650SUPER VIEW® Disposable Wide Field Lens for ZEISS RESIGHT®TS-ZR-SV404242016-09-23
00856222004827SUPER VIEW® Disposable Wide Field Lens Set for RESIGHT®40414404142016-09-23
10856222004831SUPER VIEW® Pack for ZEISS RESIGHT®TS-RP-7001402242016-09-23
10856222004848SUPER VIEW® Pack for ZEISS RESIGHT®TS-RP-7002402252016-09-23
00856222004629Insight Instruments, Inc. Infusion Cannula60013600132016-09-23
10856222004626Insight Instruments, Inc. Infusion Cannula60013600132016-09-23
10856222004046SUPER VIEW® Disposable Lens Set for RESIGHT®40219402192016-09-23
10856222004060SUPER VIEW® Disposable Lens Set for ZEISS RESIGHT®TS-ZR-LS402262016-09-23
00856222004636INTRECTOR®71004710042016-09-23
00856222004674RETRECTOR®71005710052016-09-23
00852475007004Insight Instruments, Inc. Vitreous Biopsy Probe 27 Ga71007.1002016-09-23
00852475007011Insight Instruments, Inc. Vitreous Biopsy Probe 27 Ga71007710072016-09-23
00856222004186INTRECTOR®71102711022016-09-23
00856222004193INTRECTOR®71101711012016-09-23
10856222004633INTRECTOR®71004710042016-09-23
00856222004643INTRECTOR®71004.1002016-09-23