FDA.reportPublic FDA data

#17- Teardrop Dissector, 90°, 5mm

Primary DI
00840096204803
Brand
#17- Teardrop Dissector, 90°, 5mm
Company
KATALYST SURGICAL LLC
Model
N7117-K
Device description
#17- Teardrop Dissector, 90°, 5mm
Published
2020-05-12
Public version status
New
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
00840096204803PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840096204803008400962048038400962048030840096204803

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical spatulaA hand-held manual surgical instrument designed to manipulate tissue during various types of surgical interventions. It typically consists of a flat blunt blade (no sharp edges) that is double-ended (a blade at either end) and is not constructed for one particular part of the anatomy or clinical specialty. It is usually made of high-grade stainless steel and is available with a variety of blade designs, e.g., curved and flat or straight and flat with rounded ends; some blade types may be more right-angled. The handle will be formed from its middle section and may be more prominent/serrated. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
007883297
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
00840096215380Disposable Bipolar Forceps, 8", 1.5mm Straight TipsDNK8-15SDNK8-15S2026-10-08
0081748902541323ga DEX™ Morris ILM ForcepsDVF4033-23DVF4033-232026-10-07
0084009620260127ga DEX™ Yoneda Super Grip ForcepsDVF4036-27DVF4036-272026-10-07
0084009620360823ga DEX™ Yoneda Super Grip ForcepsDVF4036-23DVF4036-232026-10-07
0084009620361525ga DEX™ Yoneda Super Grip ForcepsDVF4036-25DVF4036-252026-10-07
0084009620509125ga DEX Stiff NanoTapered Awh ForcepsDVF4005-25-SDVF4005-25-S2026-10-07
0084009620510725ga DEX Stiff Morris Honey Badger ForcepsDVF4010-25-SDVF4010-25-S2026-10-07
0084009620511425ga DEX Stiff Asymmetrical Tano ForcepsDVF4014-25-SDVF4014-25-S2026-10-07
0084009620512125ga (0.50mm) Dex™ Stiff Serrated Jaw ForcepsDVF4016-25-SDVF4016-25-S2026-10-07
0084009620513825ga DEX Stiff Maculorhexis ForcepsDVF4019-25-SDVF4019-25-S2026-10-07
0084009620514525ga DEX Stiff End Grasper ForcepsDVF4022-25-SDVF4022-25-S2026-10-07
0084009620515225ga DEX Stiff Morris ILM ForcepsDVF4033-25-SDVF4033-25-S2026-10-07
0084009620516925ga DEX™ Stiff Super Grip ForcepsDVF4034-25-SDVF4034-25-S2026-10-07
0084009620518325ga DEX Stiff Curved Horizontal ScissorsDVS5006-25-SDVS5006-25-S2026-10-07
0084009620519025ga DEX Stiff Vertical ScissorsDVS5101-25-SDVS5101-25-S2026-10-07
00840096215335Disposable Bipolar Forceps, 7", 0.5mm Straight TipsDNK7-05SDNK7-05S2026-10-07
00840096215342Disposable Bipolar Forceps, 7", 1.0mm Straight TipsDNK7-10SDNK7-10S2026-10-07
00840096215359Disposable Bipolar Forceps, 7", 1.5mm Straight TipsDNK7-15SDNK7-15S2026-10-07
00840096215366Disposable Bipolar Forceps, 8", 0.5mm Straight TipsDNK8-05SDNK8-05S2026-10-07
00840096215373Disposable Bipolar Forceps, 8", 1.0mm Straight TipsDNK8-10SDNK8-10S2026-10-07

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05056785304739Koch SpatulaBLINK MEDICAL LIMITEDHND2026-10-21
00190776434625MillenniumAvalign Technologies, Inc.HND2026-10-12
G346EC1734SS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-10-01
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00190776431464MillenniumAvalign Technologies, Inc.HND2026-09-22
00190776427801MillenniumAvalign Technologies, Inc.HND2026-08-26
00190776427924MillenniumAvalign Technologies, Inc.HND2026-08-26
B382S344933000Surgical DirectSurgical Direct, Inc.HND2026-07-31
B382S340861270Surgical DirectSurgical Direct, Inc.HND2026-07-29
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00190776403836MillenniumAvalign Technologies, Inc.HND2026-07-21
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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
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00757770520138Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
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G346EP02SSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-04-23