FDA.reportPublic FDA data

AGRICOLA RETRACTOR 3 X 3 PRG.

Primary DI
G006D1095500
Brand
AGRICOLA RETRACTOR 3 X 3 PRG.
Company
DAUD JEE MFG. CO
Model
D10-9550
Catalog number
D10-9550
Device description
To retract open the eyelids to keep eyes open during surgery over the eyeball
Published
2022-12-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HNIRetractor, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNIRetractor, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G006D1095500PrimaryHIBCC0

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
"[""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
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

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