FDA.reportPublic FDA data

Synergetics

Primary DI
10841305103730
Brand
Synergetics
Company
SYNERGETICS USA, INC.
Model
11.28S
Catalog number
11.28S
Device description
Kryptonite™ Pincer End Grip Forceps, Diamonized, Small Handle
Published
2020-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841305103730PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084130510373010841305103730

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic soft-tissue manipulation forceps, probe-like, reusableA hand-held manual instrument designed to grasp and manipulate intraocular tissues during ophthalmic surgery (e.g., anterior segment surgery, vitreo-retinal procedures, iridectomy, capsulorhexis). It has a probe-like design with a proximal handle (typically cylindrical), a thin cannula-like shaft, and small jaw-like grasping blades that protrude from the distal end of the shaft. This is a reusable device intended to be sterilized prior to use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature59 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021056726
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841305101118Synergetics18067180672020-09-18
10841305101064Synergetics18060180602020-05-31
10841305101071Synergetics18061180612020-05-31
10841305101088Synergetics18063180632020-05-31
10841305101095Synergetics18064180642020-05-31
10841305101125Synergetics18069180692020-05-31
10841305101132Synergetics18069W18069W2020-05-31
10841305101156Synergetics31.0231.022020-09-18
10841305101163Synergetics41.0041.002020-09-18
10841305101231Synergetics16579165792020-09-18
10841305101255Synergetics12.06.2512.06.252020-09-18
10841305101309Synergetics17570175702017-12-30
10841305101316Synergetics17580175802020-09-18
10841305101323Synergetics17680176802020-09-18
10841305101330Synergetics19020190202020-09-18
10841305101415Synergetics30.08.2330.08.232020-09-18
10841305101422Synergetics30.08.2530.08.252020-09-18
10841305101439Synergetics30.08.2730.08.272020-09-18
10841305101446Synergetics30.1030.102020-09-18
10841305101453Synergetics30.10.2330.10.232020-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810220800584Adler Instrument CompanyAdler, Inc.MDM2026-09-30
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00888867621237Arthrex®ARTHREX, INC.MDM2026-09-28
10888277689251MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689268MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689282MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689299MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689305MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689312MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689329MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689336MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689343MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689350MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
20888277689272MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277688988MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689190MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
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10888277689213MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
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10888277689237MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689244MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
20888277688978MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10080196320899MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
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10080196321414MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
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10080196321452MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321469MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321476MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25