FDA.reportPublic FDA data

Insight Instruments, Inc. Vitreous Biopsy Probe 27 Ga

Primary DI
00852475007004
Brand
Insight Instruments, Inc. Vitreous Biopsy Probe 27 Ga
Company
INSIGHT INSTRUMENTS, INC.
Model
71007.100
Device description
1 Each Sterile Disposable 27 Ga Vitreous Biopsy 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
00852475007004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852475007004008524750070048524750070040852475007004

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 Gauge27Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

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
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
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
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
00856222004643INTRECTOR®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