FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382S34032100T0
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
S34032.100T
Catalog number
S34032.100T
Device description
Anis Bal Tip Manipulator, Angled, Curved Dital Tip, Elongated Ball 0.6mm x 0.8mm, Titanium
Published
2023-05-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
B382S34032100T0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Intraocular retractor, reusableA dedicated ophthalmic surgical instrument intended to be used explicitly for the temporary mechanical retraction/dilatation of intraocular tissues (e.g., iris) during ophthalmic surgery. It is typically a small hook-like device which may include a retention bead or a self-retaining ring/frame, and is designed to be manipulated using another ophthalmic instrument; it is not a hand-held ophthalmic hook. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
124367223
Device count
1
Premarket exempt
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
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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
G346EP204R0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2025-11-05
05056785302636Connor Wand - StraightBLINK MEDICAL LIMITEDHND2025-11-05
04058935012939Spatula Phaco KochBausch & Lomb GmbHHND2025-10-26
04058935012953Spatula JohnsonBausch & Lomb GmbHHND2025-10-26
04058935012779Fogla Trifacet SpatulaBausch & Lomb GmbHHND2025-10-24