FDA.reportPublic FDA data

Ear Pick Tip, 90

Primary DI
00385640000239
Brand
Ear Pick Tip, 90
Company
Summit Medical, Inc.
Model
PX-1090
Catalog number
PX-1090
Published
2016-08-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JYTPick, Microsurgical Ear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYTPick, Microsurgical EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10385640000236PackageGS16In Commercial Distribution
00385640000239PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038564000023610385640000236
00385640000239003856400002393856400002390385640000239

GMDN Terms#

Term, Definition table
TermDefinition
Middle ear pickA fine, hand-held manual surgical instrument intended to be used to manipulate the structures of the middle ear (e.g., the stapes). It is typically comprised of a proximal handle that tapers to a shaft which terminates in a fine distal tip bent at 90 degrees to the shaft. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-229-2875customerservice@summitmedicalusa.com

Regulatory Flags#

DUNS number
965484699
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00385640072403Quintess®16572026-05-13
00385640072410Quintess®16582026-05-13
00385640091794INSTRUSAFEIN-2020-77532026-05-13
00385640091800INSTRUSAFEIN-2020-78032026-05-13
00385640091817INSTRUSAFEIN-2020-77512026-05-13
00385640091824INSTRUSAFEIN-2020-77932026-05-13
00385640091831INSTRUSAFEIN-2020-77042026-05-13
00385640091848INSTRUSAFEIN-2020-72672026-05-13
00385640091855INSTRUSAFEIN-2550-05-EN-0622026-05-13
00385640091862INSTRUSAFEIN-2550-05-EN-0632026-05-13
00385640091879INSTRUSAFEIN-2550-05-EN-0642026-05-13
00385640091886INSTRUSAFEIN-2550-05-EN-0652026-05-13
00385640091893INSTRUSAFEIN-2600-04-EN-0852026-05-13
00385640091909INSTRUSAFEIN-2020-76362026-05-13
00385640091916INSTRUSAFEIN-2020-76942026-05-13
00385640091923INSTRUSAFEIN-2020-77962026-05-13
00385640091930INSTRUSAFEIN-2020-78852026-05-13
00385640091947INSTRUSAFEIN-2020-78272026-05-13
00385640091954INSTRUSAFEIN-2020-78302026-05-13
00385640091961INSTRUSAFEIN-2020-78292026-05-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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09348811150325INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-05-29
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09348811150400INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-05-29
09348811150417INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-05-29
00190776421571MillenniumAvalign Technologies, Inc.JYT2026-05-05
09348811111975INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-04-24
09348811022677INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-03-18
09348811111906INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-03-16
09348811112002INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-03-16
09348811111968INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-23
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09348811155344INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-23
09348811109828INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-21
09348811109835INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-21
09348811109842INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-21
09348811109859INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-21
09348811111913INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-21
09348811111920INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-21
09348811111937INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-21
09348811150295INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-21
00190776413200MillenniumAvalign Technologies, Inc.JYT2025-10-09
G04365983B0BEARBear-Ent, LLCJYT2024-02-03
14026704804662PILLINGTELEFLEX INCORPORATEDJYT2022-12-08
14026704804679PILLINGTELEFLEX INCORPORATEDJYT2022-12-08
14026704804686PILLINGTELEFLEX INCORPORATEDJYT2022-12-08