FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382S34415250
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
S34415.25
Catalog number
S34415.25
Device description
5 Inch Meyerhoefer Chalazion Curette, Flat Handle W/ Polished Finished #3
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
HNZCurette, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNZCurette, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382S34415250PrimaryHIBCC0

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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B382SD512531140Surgical DirectSD51253114SD512531142026-02-03
B382SD77321140Surgical DirectSD7732114SD77321142026-02-03
B382SD97321140Surgical DirectSD9732114SD97321142026-02-02
B382SD97321150Surgical DirectSD9732115SD97321152026-02-02
B382SD97331160Surgical DirectSD9733116SD97331162026-02-02
B382SD51531140Surgical DirectSD5153114SD51531142025-12-02
B382SD65331140Surgical DirectSD6533114SD65331142025-12-02
B382SD67511170Surgical DirectSD6751117SD67511172025-06-04
B382SD95321140Surgical DirectSD9532114SD95321142025-06-04
B382SD84531130Surgical DirectSD8453113SD84531132025-04-03
B382SD92422150Surgical DirectSD9242215SD92422152025-03-17
B382SD512531150Surgical DirectSD51253115SD512531152025-03-10
B382SD123200Surgical DirectSD12320SD123202024-12-12
B382SD52321110Surgical DirectSD5232111SD52321112024-08-08
B382SD82421110Surgical DirectSD8242111SD82421112024-08-01
B382SD81531140Surgical DirectSD8153114SD81531142024-03-12
B382SD82131160Surgical DirectSD8213116SD82131162024-03-12
B382SD42531170Surgical DirectSD4253117SD42531172024-02-23
B382SD4810450Surgical DirectSD481045SD4810452024-01-31
B382SD77311150Surgical DirectSD7731115SD77311152023-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
04058935012687Meyerhoefer Chalazion CuretteBausch & Lomb GmbHHNZ2025-07-10
04058935012694Meyerhoefer Chalazion CuretteBausch & Lomb GmbHHNZ2025-07-10
04058935012700Meyerhoefer Chalazion CuretteBausch & Lomb GmbHHNZ2025-07-10
04058935012717Skeele CuretteBausch & Lomb GmbHHNZ2025-07-10
G412PH62530MR PHACOCrestpoint Management LimitedHNZ2025-06-09
00194613005153MSI Precision Specialty InstrumentsMed Saver, Inc.HNZ2025-03-21
00194613021542MSI Precision Specialty InstrumentsMed Saver, Inc.HNZ2025-03-21
00757770523443Bausch + LombBausch & Lomb IncorporatedHNZ2024-11-20