FDA.reportPublic FDA data

INTRECTOR®

Primary DI
00856222004643
Brand
INTRECTOR®
Company
INSIGHT INSTRUMENTS, INC.
Model
71004.100
Device description
1 Disposable 23 Ga Vitrectomy Probe for use with the INTRECTOR® KIT
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HKPInstrument, Vitreous Aspiration And Cutting, Battery-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKPInstrument, Vitreous Aspiration And Cutting, Battery-PoweredOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856222004643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856222004643008562220046438562220046430856222004643

GMDN Terms#

Term, Definition table
TermDefinition
Vitrectomy system handpiece tipA sterile, micro-cutting device that is attached to a vitrectomy system handpiece for insertion into the eye, in order to remove (nibble away) the vitreous humour (the jelly-like substance that fills the centre of the eye) during ophthalmic surgery. The handpiece converts an energy (e.g., ultrasonic, piezoelectric) produced by a system generator into a mechanical oscillating-cutting action applied by this knife-like device. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge23Gauge

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
828348391
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
10856222004657SUPER VIEW® Disposable Wide Field Lens for ZEISS RESIGHT®TS-ZR-SV404242016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10818255010432NAMICROVISION, INC.HKP2018-01-17
10818255010487NAMICROVISION, INC.HKP2018-01-17
10818255010609NAMICROVISION, INC.HKP2018-01-17
10818255010708NAMICROVISION, INC.HKP2018-01-17
00812480010307NAMEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HKP2017-06-24
00812480010314NAMEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HKP2017-06-24
00852475007004Insight Instruments, Inc. Vitreous Biopsy Probe 27 GaINSIGHT INSTRUMENTS, INC.HKP2016-09-23
00852475007011Insight Instruments, Inc. Vitreous Biopsy Probe 27 GaINSIGHT INSTRUMENTS, INC.HKP2016-09-23
00856222004186INTRECTOR®INSIGHT INSTRUMENTS, INC.HKP2016-09-23
00856222004193INTRECTOR®INSIGHT INSTRUMENTS, INC.HKP2016-09-23
00856222004667RETRECTOR®INSIGHT INSTRUMENTS, INC.HKP2016-09-23
00812480010215NAMEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HKP2016-09-23
00812480010222NAMEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HKP2016-09-23
00812480010277NAMEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HKP2016-09-23
00812480010949NAMEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HKP2016-09-23
00812480010956NAMEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HKP2016-09-23
00812480010963NAMEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HKP2016-09-23
05050474520479AMO TAC VITRECTOMY HANDPIECEJOHNSON & JOHNSON SURGICAL VISION, INC.HKP2016-09-02
05050474520493AMO LIMBAL NEEDLE ASSEMBLYJOHNSON & JOHNSON SURGICAL VISION, INC.HKP2016-09-02
05050474520509AMO TAC INFUSION SLEEVEJOHNSON & JOHNSON SURGICAL VISION, INC.HKP2016-09-02