FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382S347081000
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
S34708.100
Catalog number
S34708.100
Device description
Lasik Flap & Track Forceps Curved On Side Of Handle, With Holes At Tips, Stainless
Published
2022-11-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HMXCannula, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMXCannula, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382S347081000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Lacrimal procedural cannulaA hand-held, manual, rigid or semi-rigid instrument intended to be inserted into the lacrimal drainage system (the lacrimal duct) to perform various ocular irrigation or aspiration procedures (e.g., lacrimal syringing). It may also be used during placement of a lacrimal tube/stent, or in procedures for the extraction of the cortex lentis or softer parts of the lens of the eye. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 519-3293info@surgicaldirect.com

Regulatory Flags#

DUNS number
124367223
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B382SD9344181000Surgical DirectSD934418100SD9344181002026-07-10
B382SD9344181010Surgical DirectSD934418101SD9344181012026-07-10
B382SD9344181020Surgical DirectSD934418102SD9344181022026-07-10
B382SD9344181030Surgical DirectSD934418103SD9344181032026-07-10
B382SD921226190Surgical DirectSD92122619SD921226192022-12-01
B382SD070823101310Surgical DirectSD07082-31013-1SD07082-31013-12026-09-30
B382SD13768330Surgical DirectSD13768-33SD13768-332026-09-30
B382SD8160490Surgical DirectSD816049SD8160492026-09-30
B382SD90293310010Surgical DirectSD9029331001SD90293310012026-09-30
B382SD907620220Surgical DirectSD90762022SD907620222026-09-30
B382SD9115011000Surgical DirectSD911501100SD9115011002026-09-30
B382SD914800210Surgical DirectSD91480021SD914800212026-09-30
B382SD9156321100Surgical DirectSD915632110SD9156321102026-09-30
B382SD921329100Surgical DirectSD92132910SD921329102026-09-30
B382SD1455810020Surgical DirectSD14558-1002SD14558-10022026-09-29
B382SD1455810030Surgical DirectSD14558-1003SD14558-10032026-09-29
B382SD30550860Surgical DirectSD30550-86SD30550-862026-09-29
B382SD49195170Surgical DirectSD49195-17SD49195-172026-09-29
B382SD4937851340Surgical DirectSD49-3785-134SD49-3785-1342026-09-29
B382SD546210000Surgical DirectSD5462-1000SD5462-10002026-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776432966MillenniumAvalign Technologies, Inc.HMX2026-09-30
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