FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD9344181000
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD934418100
Catalog number
SD934418100
Device description
4in. Heath Chalazion Curette with 0.5 mm Tip, One Sharp Edge and One Blunt Edge
Published
2026-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNZCurette, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNZCurette, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD9344181000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic curette, reusableA hand-held, manual, ophthalmic surgical instrument typically with a fenestrated, spoon-shaped or ring-like tip which can be either sharp or blunt, intended to be used to obtain or remove eye tissue through a scraping action. It is typically made of metal. This is a reusable 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B382SD9207261140Surgical DirectSD920726114SD9207261142022-12-05
B382SD905500140Surgical DirectSD90550014SD905500142022-11-30
B382SD017210000Surgical DirectSD0172-1000SD0172-10002026-08-21
B382SD13448970Surgical DirectSD13448-97SD13448-972026-08-21
B382SD16008970Surgical DirectSD16008-97SD16008-972026-08-21
B382SD161730Surgical DirectSD1617-3SD1617-32026-08-21
B382SD3028P0Surgical DirectSD3028PSD3028P2026-08-21
B382SD77205052000Surgical DirectSD77205-05-200SD77205-05-2002026-08-21
B382SD77205082000Surgical DirectSD77205-08-200SD77205-08-2002026-08-21
B382SD7720508TS2000Surgical DirectSD77205-08TS-200SD77205-08TS-2002026-08-21
B382SD77205252000Surgical DirectSD77205-25-200SD77205-25-2002026-08-21
B382SD83042110011NS0Surgical DirectSD83042-11001-1NSSD83042-11001-1NS2026-08-21
B382SD9017971000Surgical DirectSD901797100SD9017971002026-08-21
B382SD907300000Surgical DirectSD90730000SD907300002026-08-21
B382SD914775290Surgical DirectSD91477529SD914775292026-08-21
B382SD915039080Surgical DirectSD91503908SD915039082026-08-21
B382SD915039140Surgical DirectSD91503914SD915039142026-08-21
B382SD915039150Surgical DirectSD91503915SD915039152026-08-21
B382SD9227656000Surgical DirectSD922765600SD9227656002026-08-21
B382SD9144941010Surgical DirectSD914494101SD9144941012026-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776408749MillenniumAvalign Technologies, Inc.HNZ2026-08-03
B382SD9344181010Surgical DirectSurgical Direct, Inc.HNZ2026-07-10
B382SD9344181020Surgical DirectSurgical Direct, Inc.HNZ2026-07-10
B382SD9344181030Surgical DirectSurgical Direct, Inc.HNZ2026-07-10
00860015282064Intrace USAPILOTIS TECH LLCHNZ2026-07-03
05060411981133Chalazion Curette 2.5mmDTR MEDICAL LIMITEDHNZ2026-06-10
05060411983823Double Ended Chalazion Curette, 1mm & 2mm ScoopsDTR MEDICAL LIMITEDHNZ2026-06-10
05060411984424Chalazion Curette 3mmDTR MEDICAL LIMITEDHNZ2026-06-10
00757770505708Bausch + LombBausch & Lomb IncorporatedHNZ2026-04-30
04058935013288Terry Scraper Non Irr DSEKBausch & Lomb GmbHHNZ2025-10-26
00190776410780MillenniumAvalign Technologies, Inc.HNZ2025-09-12
00757770636242Bausch + LombBausch & Lomb IncorporatedHNZ2025-08-13
G2231196790Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNZ2025-08-11
00757770407583Bausch + LombBausch & Lomb IncorporatedHNZ2025-08-08
00757770415199Bausch + LombBausch & Lomb IncorporatedHNZ2025-08-08
00757770415533Bausch + LombBausch & Lomb IncorporatedHNZ2025-08-08
00757770419029Bausch + LombBausch & Lomb IncorporatedHNZ2025-08-08
00757770419401Bausch + LombBausch & Lomb IncorporatedHNZ2025-08-08
00757770433636Bausch + LombBausch & Lomb IncorporatedHNZ2025-08-08
00757770436385Bausch + LombBausch & Lomb IncorporatedHNZ2025-08-08
00194613005160MSI Precision Specialty InstrumentsMed Saver, Inc.HNZ2025-08-01
00194613087142MSI Precision Specialty InstrumentsMed Saver, Inc.HNZ2025-08-01
00194613100377MSI Precision Specialty InstrumentsMed Saver, Inc.HNZ2025-08-01
00194613101558MSI Precision Specialty InstrumentsMed Saver, Inc.HNZ2025-08-01
00194613101572MSI Precision Specialty InstrumentsMed Saver, Inc.HNZ2025-08-01
00194613103569MSI Precision Specialty InstrumentsMed Saver, Inc.HNZ2025-08-01
00194613108588MSI Precision Specialty InstrumentsMed Saver, Inc.HNZ2025-08-01
00194613113988MSI Precision Specialty InstrumentsMed Saver, Inc.HNZ2025-08-01
04058935012663Meyerhoefer Chalazion CuretteBausch & Lomb GmbHHNZ2025-07-10
04058935012670Meyerhoefer Chalazion CuretteBausch & Lomb GmbHHNZ2025-07-10