FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382S344901020
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
S34490.102
Catalog number
S34490.102
Device description
"4 5/8"" Seibel Nucleus Chopper, 15mm Bend To Tip, 0.5mm Olive Shaped Tip, Curved Inside Cutting Edge, Use in Left Hand, Right Hand Dominate, Round Knurled Handle"
Published
2026-03-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNDSpatula, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNDSpatula, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382S344901020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical probe, reusableA slender, rod-like, hand-held manual surgical instrument intended to be used during an ophthalmic procedure to explore, measure, and/or manipulate ocular tissues (e.g., retraction/manipulation of intraocular structures, lens nucleus splitting, removal of foreign bodies in the eye, LASIK flap lifting); it is neither intended to cut tissue nor hook muscles. It is available with a variety of tip shapes including blunt bulbous, hook and T-shape, and the shaft may be straight or bent; it is made of flexible or rigid metallic and/or synthetic polymer material. 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
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
00190776400385MillenniumAvalign Technologies, Inc.HND2026-07-17
G346EP175RSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-07-06
00850083275983Intrace USAPILOTIS TECH LLCHND2026-07-03
G4533306290PEAK MEDICALPeak Medical Distribution Inc.HND2026-06-24
04251047903571Rowen Phaco Spatula & Bechert Nucleus RotatorA1 Medical GmbHHND2026-06-09
00757770688548Bausch + LombBausch & Lomb IncorporatedHND2026-05-11
00190776420994MillenniumAvalign Technologies, Inc.HND2026-04-30
00757770501229Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
00757770505753Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
00757770511006Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
00757770511020Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
00757770511037Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
00757770511075Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
00757770520138Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
00757770522682Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
G346EP02SSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-04-23
G346P1607SS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-04-23
G346EC34Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-04-20
G346EP1850Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-04-02
G346EP44900Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-04-01
00841668144398KatenaKATENA PRODUCTS, INC.HND2026-03-31
00841668144404KatenaKATENA PRODUCTS, INC.HND2026-03-31
00841668144428KatenaKATENA PRODUCTS, INC.HND2026-03-31
00841668144435KatenaKATENA PRODUCTS, INC.HND2026-03-31
00841668144442KatenaKATENA PRODUCTS, INC.HND2026-03-31
05056785303350Double Ended Y and ICL Shaped ManipulatorBLINK MEDICAL LIMITEDHND2026-02-04
05056785303336Connor WandBLINK MEDICAL LIMITEDHND2026-01-26
G346EP203L0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2025-11-05
G346EP203R0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2025-11-05
G346EP204L0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2025-11-05