FDA.reportPublic FDA data

NA

Primary DI
00812480010680
Brand
NA
Company
MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.
Model
5500SST
Catalog number
5500SST
Device description
Cannula Insertion System, 27 Gauge, Sterile, Single Step, w/ Tubing Set
Published
2017-06-24
Public version status
Update
Distribution status
Not 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
HMXCannula, Ophthalmic
NGYCannula, Trocar, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMXCannula, OphthalmicOphthalmic1
NGYCannula, Trocar, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10812480010687PackageGS16Not in Commercial Distribution
00812480010680PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081248001068710812480010687
00812480010680008124800106808124800106800812480010680

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic cannulation set, single-useA collection of non-powered devices intended to be used to create a channel into the eye for posterior segment ophthalmic surgery [e.g., infusion and/or aspiration of an ophthalmic replacement medium (e.g., silicone oil)]. It consists of metal cannulae, often with tubing, and includes additional ophthalmic instruments/devices intended to support the cannulation procedure (e.g., a trocar, plug, syringe, filter); it may be used in conjunction with a dedicated pump (not included) for pressure-controlled fluid delivery. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge27Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-40 Degrees Celsius70 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity95 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
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00812480010000NA2920CE2920CE2016-09-23
00812480010093NA2450CE2450CE2016-09-23
00812480010109NA2470CE2470CE2016-09-23
00812480010116NA2490CE2490CE2016-09-23
00812480010123NA2520CE2520CE2016-09-23
00812480010413NA2500CE2500CE2016-09-23
00812480010420NA2540CE2540CE2016-09-23
00812480010437NA2900CE2900CE2016-09-23
00812480010444NA2940CE2940CE2016-09-23

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Primary DI, Brand, Company table
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08600088329110Maskin MG Probe 1mmMGD INNOVATIONS, LLCHMX2026-05-07
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