FDA.reportPublic FDA data

DRYSDALE NUCLEUS MANIPULATOR AND HOOK

Primary DI
G006DS30024180
Brand
DRYSDALE NUCLEUS MANIPULATOR AND HOOK
Company
DAUD JEE MFG. CO
Model
DS300-2418
Catalog number
DS300-2418
Device description
for manipulating tissue, rotating and cracking the nucleus
Published
2022-12-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
HNXDepressor, Orbital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNXDepressor, OrbitalOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G006DS30024180PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Eye muscle hook, reusableA hand-held manual surgical instrument designed to be used to locate and hook extraocular muscles, typically during strabismus correction surgery. It is a slender instrument with a bent blunt distal end and a handle, available in several sizes; some hooks with a very fine shank are designed to allow suture placement behind the hook, providing greater suture security (i.e., better muscle attachment). It is not designed for intraocular use. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Ethylene Oxide"", ""Moist Heat or Steam Sterilization""]"

Regulatory Flags#

DUNS number
645508946
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G006D4020160Terry Micro Corneal ScissorsD40-2016D40-20162022-12-16
G006D4020170Terry Micro Corneal ScissorsD40-2017D40-20172022-12-16
G006D9020200PLASTIC AUTOCLAVABLE TRAY 160x70x25MMD902020D9020202022-12-23
G006D9020300PLASTIC AUTOCLAVABLE TRAY 265x160x25MMD902030D9020302022-12-23
G006D9020400PLASTIC AUTOCLAVABLE TRAY 265x160x50MMD902040D9020402022-12-23
G006DJ087300S.S PEEL POCH RACKS, 5A, 230x102x102 MM, 5 SPACESDJ08730DJ087302022-12-16
G006DJ087310S.S PEEL POCH RACKS, 10A, 470x102x102 MM, 10 SPACESDJ08731DJ087312022-12-16
G006DJ087320S.S PEEL POCH RACKS, 21,483x102x102 MM, 21 SPACESDJ08732DJ087322022-12-16
G006DJ087330S.S PEEL POCH RACKS, 13, 533x203x203 MM, 6 & 7 SPACESDJ08733DJ087332022-12-16
G006DJ087340S.S PEEL POCH RACKS, 18B, 533x203x203 MM, 10 SPACESDJ08734DJ087342022-12-16
G006DJ087350S.S PEEL POCH RACKS, 8, 510x152x152 MM, 8 SPACESDJ08735DJ087352022-12-16
G006DJ087360S.S PEEL POCH RACKS, 4A, 510x152x152 MM, 4 SPACESDJ08736DJ087362022-12-16
G006DJ087370S.S PEEL POCH RACKS, 5B, 510x180x102 MM, 5 SPACESDJ08737DJ087372022-12-16
G006DJ087380S.S PEEL POCH RACKS, 4B, 406x180x102 MM, 4 SPACESDJ08738DJ087382022-12-16
G006DJ23430FULL MICRO PERFORATED TRAYS WITH LID 40x40x20MMDJ2343DJ23432022-12-23
G006DJ23440FULL MICRO PERFORATED TRAYS WITH LID 70x70x30MMDJ2344DJ23442022-12-23
G006DJ23450FULL MICRO PERFORATED TRAYS WITH LID 80x40x20MMDJ2345DJ23452022-12-23
G006DJ23460FULL MICRO PERFORATED TRAYS WITH LID 80x40x30MMDJ2346DJ23462022-12-23
G006DJ23470FULL MICRO PERFORATED TRAYS WITH LID 80x80x34MMDJ2347DJ23472022-12-23
G006DJ23480FULL MICRO PERFORATED TRAYS WITH LID 80x80x40MMDJ2348DJ23482022-12-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04547451339212INAMIINAMI & CO., LTD.HNX2026-01-29
04547451339045InamiINAMI & CO., LTD.HNX2025-12-05
04058935013394Depressor Scleral FlynnBausch & Lomb GmbHHNX2025-10-26
00757770483235Bausch + LombBausch & Lomb IncorporatedHNX2025-08-08
00757770498765Bausch + LombBausch & Lomb IncorporatedHNX2025-08-08
00757770500444Bausch + LombBausch & Lomb IncorporatedHNX2025-08-08
00757770524914Bausch + LombBausch & Lomb IncorporatedHNX2025-08-08
00194613011604MSI Precision Specialty InstrumentsMed Saver, Inc.HNX2025-08-01
00194613011628MSI Precision Specialty InstrumentsMed Saver, Inc.HNX2025-08-01
00194613109738MSI Precision Specialty InstrumentsMed Saver, Inc.HNX2025-08-01
G412DP20600MR PHACOCrestpoint Management LimitedHNX2025-05-27
00194613119959MSI Precision Specialty InstrumentsMed Saver, Inc.HNX2025-03-21
00757770406685Bausch + LombBausch & Lomb IncorporatedHNX2024-11-20
00757770414703Bausch + LombBausch & Lomb IncorporatedHNX2024-11-20
00757770425136Bausch + LombBausch & Lomb IncorporatedHNX2024-11-20
00757770432097Bausch + LombBausch & Lomb IncorporatedHNX2024-11-20
00757770435326Bausch + LombBausch & Lomb IncorporatedHNX2024-11-20
00192896120273Schepens Scleral DepressorSONTEC INSTRUMENTS, INC.HNX2024-10-15
00757770426676Bausch + LombBausch & Lomb IncorporatedHNX2024-08-26
00887482049297Symmetry HarmsASPEN SURGICAL PRODUCTS, INC.HNX2024-08-20
00194613087753MSI Precision Specialty InstrumentsMed Saver, Inc.HNX2024-08-15
00194613087760MSI Precision Specialty InstrumentsMed Saver, Inc.HNX2024-08-15
00194613087777MSI Precision Specialty InstrumentsMed Saver, Inc.HNX2024-08-15
00194613087821MSI Precision Specialty InstrumentsMed Saver, Inc.HNX2024-08-15
00887482111475Symmetry SchepensASPEN SURGICAL PRODUCTS, INC.HNX2024-08-12
00887482111482Symmetry SchepensASPEN SURGICAL PRODUCTS, INC.HNX2024-08-12
00887482111499Symmetry FlynnASPEN SURGICAL PRODUCTS, INC.HNX2024-08-12
00840183521998BR Surgical, LLCBR Surgical, LLCHNX2024-06-03
08175700156110Scleral DepressorsAURORA SURGICAL, LLCHNX2024-02-06
08175700156127Scleral DepressorsAURORA SURGICAL, LLCHNX2024-02-06