FDA.reportPublic FDA data

Integra®

Primary DI
10381780084648
Brand
Integra®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
3724316
Catalog number
3724316
Device description
Integra® Shea Speculum Holder
Published
2018-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JYKHOLDER, EAR SPECULUM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYKHolder, Ear SpeculumGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780084648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178008464810381780084648

GMDN Terms#

Term, Definition table
TermDefinition
ENT speculum holderA device intended to be used to secure an ear/nose/throat (ENT) speculum in a fixed position to enable a surgeon to remain hands-free during a surgical intervention. The holder is typically fastened to the side rail of the operating table and can be adjusted to a desired position. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
081277700
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
10381780024507Integra® Jarit®100539100-5392018-01-22
10381780024514Integra® Jarit®100540100-5402018-01-22
10381780031901Integra® Miltex®27-20227-2022015-09-22
10381780031918Integra® Miltex®27-20427-2042015-09-22
10381780031925Integra® Miltex®27-20627-2062015-09-22
10381780031932Integra® Miltex®27-20827-2082015-09-22
10381780031949Integra® Miltex®27-21027-2102015-09-22
10381780031956Integra® Miltex®27-21227-2122015-09-22
10381780063865Integra® Miltex®4-515C4-515C2018-02-15
10381780063872Integra® Miltex®4-5224-5222018-02-15
10381780063896Integra® Miltex®461146112018-02-15
10381780063902Integra® Miltex®461546152018-02-15
10381780064206Integra® Miltex®33-3833-382018-02-14
10381780128779Integra® Miltex®30-174030-17402016-08-03
10381780133810Integra® Jarit®320437320-4372016-08-12
10381780134503Integra® Jarit®6531016531012018-01-15
10381780136408Integra® Jarit®X37254X372542016-08-14
10381780142874Integra® Jarit®230250230-2502016-08-14
10381780143048Integra® Jarit®320195320-1952016-08-14
10381780143055Integra® Jarit®320196320-1962016-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250676730015MENTIO disposable ear speculaSpiggle & Theis Medizintechnik GmbHJYK2025-10-07
04250676730022MENTIO disposable ear speculaSpiggle & Theis Medizintechnik GmbHJYK2025-10-07
04250676730039MENTIO disposable ear speculaSpiggle & Theis Medizintechnik GmbHJYK2025-10-07
04250676730046MENTIO disposable ear speculaSpiggle & Theis Medizintechnik GmbHJYK2025-10-07
04250676734884MENTIO disposable cerumen hookSpiggle & Theis Medizintechnik GmbHJYK2025-10-07
04250676746634MENTIO disposable ear curette/cottonSpiggle & Theis Medizintechnik GmbHJYK2025-10-07
00840183527402BR Surgical, LLCBR Surgical, LLCJYK2024-11-26
G043606200BEARBear-Ent, LLCJYK2023-03-06
G043606220BEARBear-Ent, LLCJYK2023-03-06
G043606230BEARBear-Ent, LLCJYK2023-03-06
G043606280BEARBear-Ent, LLCJYK2022-06-01
B351GC03800mytaMedMytamed, Inc.JYK2021-02-11
B351BGC03800BEARMytamed, Inc.JYK2021-01-18
B351BMN1699V0BEARMytamed, Inc.JYK2021-01-18
04046826110222MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJYK2020-09-24
04046826101787MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJYK2020-09-24
24026704526745PILLINGTELEFLEX INCORPORATEDJYK2018-09-15
00821925011663Gyrus ACMIGyrus ACMI, LLCJYK2018-09-07
00821925011670GYRUS ACMI, INCGyrus ACMI, LLCJYK2018-09-07
00821925011687GYRUS ACMI, INCGyrus ACMI, LLCJYK2018-09-07
00821925011694Gyrus ACMIGyrus ACMI, LLCJYK2018-09-07
10381780110866MicroFrance®INTEGRA MICROFRANCEJYK2018-01-12
10381780110873MicroFrance®INTEGRA MICROFRANCEJYK2018-01-12
10381780110897MicroFrance®INTEGRA MICROFRANCEJYK2018-01-12
10381780110910MicroFrance®INTEGRA MICROFRANCEJYK2018-01-12
10381780110835MicroFrance®INTEGRA MICROFRANCEJYK2018-01-12