FDA.reportPublic FDA data

Bi-Blade®

Primary DI
00812480011021
Brand
Bi-Blade®
Company
MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.
Model
2390BB
Catalog number
2390BB
Device description
25 Gauge BB Vitreous Cutter, 20 psi, Luer Anterior PVC Tubing Set, Sterile, Single Use
Published
2018-11-16
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
HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQEInstrument, Vitreous Aspiration And Cutting, Ac-PoweredOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153168000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153168000Bi-Blade Vitrectomy CutterMedical Instrument Development Laboratories2016-04-29HQE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10812480011028PackageGS16In Commercial Distribution
00812480011021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081248001102810812480011028
00812480011021008124800110218124800110210812480011021

GMDN Terms#

Term, Definition table
TermDefinition
Vitrectomy system micro-cutting unitA sterile, pneumatically-powered, hand-held cutting tool that incorporates a vitrectomy system handpiece, micro-tip and connecting tubing as a single unit, intended to remove (nibble away) vitreous humour (the jelly-like substance that fills the centre of the eye) during ophthalmic surgery. The tubing transmits pneumatic power produced by a system generator to the handpiece which converts this into a mechanical oscillating-cutting action at the tip. This device will typically be activated by the surgeon using a foot control and provide or support the irrigation/suction systems needed to supply replacement fluid and remove debris. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge25Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity98 Percent (%) Relative Humidity
Handling Environment Temperature-40 Degrees Celsius70 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity98 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1(800)929-5227qa@midlabs.com

Regulatory Flags#

DUNS number
790265227
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812480011083Bi-Blade®2620BB2620BB2026-09-26
00812480011090Bi-Blade®2640BB2640BB2026-09-26
00812480011137Bi-Blade®2810BB2810BB2026-09-27
00812480011144Bi-Blade®2870BB2870BB2026-09-26
00812480011151Bi-Blade®2890BB2890BB2026-09-27
00812480011168Bi-Blade®2910BB2910BB2026-09-27
00812480011175Bi-Blade®2970BB2970BB2026-09-27
00812480011182Bi-Blade®2990BB2990BB2026-09-27
00812480013049NA2700CN2700CN2026-09-27
00812480011038Bi-Blade®2410BB2410BB2023-08-14
00812480011007Bi-Blade®2310BB2310BB2023-08-14
10812480011035Bi-Blade®2410BB2410BB2023-08-14
00812480011045Bi-Blade®2510BB2510BB2018-11-16
00812480010741Bi-Blade®2320BB2320BB2018-09-24
00812480010826Bi-Blade®2520BB2520BB2018-09-24
00812480010833Bi-Blade®2540BB2540BB2018-09-24
00812480010840Bi-Blade®2560BB2560BB2018-09-24
00812480010918Bi-Blade™2920BB2920BB2018-09-24
00812480010925Bi-Blade™2940BB2940BB2018-09-24
00812480010932Bi-Blade™2960BB2960BB2018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812480011137Bi-Blade®MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HQE2026-09-27
00812480011151Bi-Blade®MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HQE2026-09-27
00812480011168Bi-Blade®MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HQE2026-09-27
00812480011175Bi-Blade®MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HQE2026-09-27
00812480011182Bi-Blade®MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HQE2026-09-27
00812480013049NAMEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HQE2026-09-27
00812480011083Bi-Blade®MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HQE2026-09-26
00812480011090Bi-Blade®MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HQE2026-09-26
00812480011144Bi-Blade®MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.HQE2026-09-26
10757770060464Bausch + LombBausch & Lomb IncorporatedHQE2026-04-09
10757770060471Bausch + LombBausch & Lomb IncorporatedHQE2026-04-09
10757770060488Bausch + LombBausch & Lomb IncorporatedHQE2026-04-09
00380650003294UNITYAlcon Laboratories, Inc.HQE2025-04-08
0871787203654027G Two Dimensional Cutter – 20k CPMD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2025-04-01
08717872036526EVA Cartridge with 0.5 L Collection BagD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2025-03-31
08717872036588Disposable EVA Air Fluid Dual Tubing D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2025-03-31
08717872036489EVA NEXUS™ Irrigation and Aux. Aspiration TubingD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2025-03-31
08717872036496EVA NEXUS™ Infusion Giving SetD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2025-03-31
08717872036502EVA Nexus™ Irrigation TubingD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2025-03-31
08717872036618EVA Nexus™ Aux. Aspiration TubingD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2025-03-31
08717872036625EVA NEXUS™ cartridge with 0,5 L collection bagD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2025-03-31
08717872034713CUSTOM TDC VITREC.PACK VGP 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2024-09-27
00380650001252UNITYAlcon Laboratories, Inc.HQE2024-07-02
08717872035109EVA NEXUS™ Posterior 23G TDC PackD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2024-02-21
08717872035116EVA NEXUS™ Posterior 25G TDC PackD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2024-02-21
08717872035123EVA NEXUS™ Posterior 27G TDC PackD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2024-02-21
08717872035307EVA NEXUS™ Posterior 23G TDC PackD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2024-02-21
08717872035314EVA NEXUS™ Posterior 25G TDC PackD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2024-02-21
08717872035321EVA NEXUS™ Posterior 27G TDC PackD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2024-02-21
08717872035338EVA NEXUS™ Combined 23G TDC PackD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2024-02-21