FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382S344933000
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
S34493.300
Catalog number
S34493.300
Device description
Terry DSEK Scraper, Hole-Shaped Scraper Facing Upwards, 0.4 mm Posterior Port, Angled 11 mm Bend to Tip
Published
2026-07-31
Public version status
New
Distribution status
Not 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
HNDSpatula, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNDSpatula, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382S344933000PrimaryHIBCC0

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
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
B382SD309390Surgical DirectSD30939SD309392026-10-20
B382SD4810110Surgical DirectSD48-1011SD48-10112026-10-20
B382SD62362020Surgical DirectSD62362-02SD62362-022026-10-20
B382SD907310070Surgical DirectSD90731007SD907310072026-10-20
B382SD915070010Surgical DirectSD91507001SD915070012026-10-20
B382SD915070020Surgical DirectSD91507002SD915070022026-10-20
B382SD915070030Surgical DirectSD91507003SD915070032026-10-20
B382SD915758300Surgical DirectSD91575830SD915758302026-10-20
B382SD917665100Surgical DirectSD91766510SD917665102026-10-20
B382SD917665110Surgical DirectSD91766511SD917665112026-10-20
B382SD917665120Surgical DirectSD91766512SD917665122026-10-20
B382SD917665700Surgical DirectSD91766570SD917665702026-10-20
B382SD917665920Surgical DirectSD91766592SD917665922026-10-20
B382SD917665930Surgical DirectSD91766593SD917665932026-10-20
B382SD9210921080Surgical DirectSD921092108SD9210921082026-10-20
B382SD922624103T0Surgical DirectSD922624103TSD922624103T2026-10-20
B382SD9228132200Surgical DirectSD922813220SD9228132202026-10-20
B382SD9228132210Surgical DirectSD922813221SD9228132212026-10-20
B382SD9228132220Surgical DirectSD922813222SD9228132222026-10-20
B382SD9228132300Surgical DirectSD922813230SD9228132302026-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776434625MillenniumAvalign Technologies, Inc.HND2026-10-12
G346EC1734SS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-10-01
03700483630240MORIAMORIA SAHND2026-09-25
00190776431464MillenniumAvalign Technologies, Inc.HND2026-09-22
00190776427801MillenniumAvalign Technologies, Inc.HND2026-08-26
00190776427924MillenniumAvalign Technologies, Inc.HND2026-08-26
B382S340861270Surgical DirectSurgical Direct, Inc.HND2026-07-29
G346EP400Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-07-23
00190776403836MillenniumAvalign Technologies, Inc.HND2026-07-21
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