FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD9345411050
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD934541105
Catalog number
SD934541105
Device description
Osher Neuman 8 Line Corneal Marker
Published
2022-12-03
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
HMRMarker, ocular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMRMarker, OcularOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD9345411050PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Corneal marker, single-useA manual instrument intended to be used to ink mark corneal tissue prior to an ophthalmic surgical procedure. It is a pen-like device typically with a weighted self-levelling mechanism. 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
B382SD89239290Surgical DirectSD8923-929SD8923-9292026-07-17
B382SD89509290Surgical DirectSD8950-929SD8950-9292026-07-17
B382SD89529290Surgical DirectSD8952-929SD8952-9292026-07-17
B382SD89759150Surgical DirectSD8975-915SD8975-9152026-07-17
B382SD89819320Surgical DirectSD8981-932SD8981-9322026-07-17
B382SD89839280Surgical DirectSD8983-928SD8983-9282026-07-17
B382SD89839290Surgical DirectSD8983-929SD8983-9292026-07-17
B382SD89914450Surgical DirectSD8991445SD89914452026-07-17
B382SD9013461020Surgical DirectSD901346102SD9013461022026-07-17
B382SD9070791100Surgical DirectSD907079110SD9070791102026-07-17
B382SD9073531010Surgical DirectSD907353101SD9073531012026-07-17
B382SD90738400T0Surgical DirectSD90738400TSD90738400T2026-07-17
B382SD9073931130Surgical DirectSD907393113SD9073931132026-07-17
B382SD9074751070Surgical DirectSD907475107SD9074751072026-07-17
B382SD9075041030Surgical DirectSD907504103SD9075041032026-07-17
B382SD907505200Surgical DirectSD90750520SD907505202026-07-17
B382SD907505210Surgical DirectSD90750521SD907505212026-07-17
B382SD907530128T0Surgical DirectSD907530128TSD907530128T2026-07-17
B382SD907530129T0Surgical DirectSD907530129TSD907530129T2026-07-17
B382SD907573330Surgical DirectSD90757333SD907573332026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700483628179MORIAMORIA SAHMR2026-07-16
03700483628209MORIAMORIA SAHMR2026-07-16
03700483628261MORIAMORIA SAHMR2026-07-16
04251047934674Gerten Cornea Zone MarkerA1 Medical GmbHHMR2026-05-29
00757770714643Bausch + LombBausch & Lomb IncorporatedHMR2026-05-11
00757770520114Bausch + LombBausch & Lomb IncorporatedHMR2026-04-30
00840516145808Anodyne SurgicalPsi/Eye-Ko, Inc.HMR2026-04-17
00840516145815Anodyne SurgicalPsi/Eye-Ko, Inc.HMR2026-04-17
00190776420482MillenniumAvalign Technologies, Inc.HMR2026-04-16
00190776420062MillenniumAvalign Technologies, Inc.HMR2026-04-15
00190776419387MillenniumAvalign Technologies, Inc.HMR2026-04-14
00190776418984MillenniumAvalign Technologies, Inc.HMR2026-04-13
00841668144299KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144305KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144312KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144329KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144336KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144343KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144350KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144367KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144374KatenaKATENA PRODUCTS, INC.HMR2026-03-31
G346BP01RSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMR2026-03-02
G346ET160Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMR2026-02-17
00642356004709Mastel Surgical Inc.Mastel Surgical Inc.HMR2026-02-11
B382S34556140Surgical DirectSurgical Direct, Inc.HMR2026-02-04
B382S4901000Surgical DirectSurgical Direct, Inc.HMR2026-02-04
B382S5616020Surgical DirectSurgical Direct, Inc.HMR2026-02-04
G346ET390Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMR2026-01-21
B382S345201000Surgical DirectSurgical Direct, Inc.HMR2025-12-10
G22312270490Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMR2025-11-05