FDA.reportPublic FDA data

NA

Primary DI
00812480010703
Brand
NA
Company
MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.
Model
5600GST
Catalog number
5600GST
Device description
Cannula Insertion System, 25 Gauge, Sterile, Single Step GEN II, w/ Tubing Set
Published
2017-06-24
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
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
10812480010700PackageGS16In Commercial Distribution
00812480010703PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081248001070010812480010700
00812480010703008124800107038124800107030812480010703

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 Gauge25Gauge

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
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
00190776428228MillenniumAvalign Technologies, Inc.HMX2026-08-27
00840285320802Walcott Rx productsWalcott Rx Product IncHMX2026-08-18
00190776425821MillenniumAvalign Technologies, Inc.HMX2026-08-17
00840319759271Hayden MedicalHayden Medical, Inc.HMX2026-08-14
G223140475250Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMX2026-08-03
B382S34701200Surgical DirectSurgical Direct, Inc.HMX2026-07-31
B382S347061000Surgical DirectSurgical Direct, Inc.HMX2026-07-31
B382S34745150Surgical DirectSurgical Direct, Inc.HMX2026-07-31
B382S347671000Surgical DirectSurgical Direct, Inc.HMX2026-07-31
B382S347891000Surgical DirectSurgical Direct, Inc.HMX2026-07-31
B382S347891190Surgical DirectSurgical Direct, Inc.HMX2026-07-31
B382S347911020Surgical DirectSurgical Direct, Inc.HMX2026-07-31
G223140190270Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMX2026-07-27
00190776403843MillenniumAvalign Technologies, Inc.HMX2026-07-21
00190776400569MillenniumAvalign Technologies, Inc.HMX2026-07-19
00860015282040Intrace USAPILOTIS TECH LLCHMX2026-07-03
00840285320796Walcott Rx ProductsWalcott Rx Product IncHMX2026-06-26
00840319759189Hayden MedicalHayden Medical, Inc.HMX2026-06-24
04251047903151Nagahara Phaco-ChopperA1 Medical GmbHHMX2026-06-09
04251047903175Nagahara Phaco-ChopperA1 Medical GmbHHMX2026-06-09
04251047903632Chang Phaco ChopperA1 Medical GmbHHMX2026-06-09
04251047903755Nagahara Phaco-ChopperA1 Medical GmbHHMX2026-06-09
04251047915086Akahoshi Combo Pre-ChopperA1 Medical GmbHHMX2026-05-29
04251047923296Rycroft Air Injection CannulaA1 Medical GmbHHMX2026-05-29
04251047923388Sauter Hydrodissection CannulaA1 Medical GmbHHMX2026-05-29
04251047933295Gerten Clear Cornea DALK CannulaA1 Medical GmbHHMX2026-05-29
04251047934520Gerten Easy Liquid Bubble DMEK CannulaA1 Medical GmbHHMX2026-05-29
08600088329110Maskin MG Probe 1mmMGD INNOVATIONS, LLCHMX2026-05-07
G22312643590Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMX2026-04-09
G223140461200Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMX2026-04-09