FDA.reportPublic FDA data

Integra®

Primary DI
10381780081906
Brand
Integra®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
3722069
Catalog number
3722069
Device description
Integra® House Hook, 1mm Long Rounded Dull Tip Angled 90 Degree, Shaft Angled Left
Published
2018-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JYLHOOK, MICROSURGICAL EAR

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780081906PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178008190610381780081906

GMDN Terms#

Term, Definition table
TermDefinition
Middle ear incus hookA shaft-like, hand-held manual surgical instrument intended to be used during ear/nose/throat (ENT) surgery for fixation or traction of the incus bone (the anvil bone of the group of three that form the sound-transmitting ossicles in the middle ear). The device tapers towards the distal end to form a hook or multiple hooks used in the procedure. The proximal end forms a handle which may vary in shape. In multiple hook designs, the hooks are in parallel. 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780156802Integra® Ruggles®-Redmond™RN2528RN25282016-08-14
10381780167075Integra® Jarit®500105500-1052018-04-09
10381780394761Integra® Jarit®500100500-1002018-04-09
10381780394778Integra® Jarit®500110500-1102018-04-09
10381780394808Integra® Jarit®500135500-1352018-04-09
10381780435860Integra® Miltex®30-3030-302018-01-24
10381780435907Integra® Miltex®30-5530-552018-01-24
10381780435952Integra® Miltex®30-6230-622018-01-24
10381780488248Integra® Miltex®MH30-10MH30-102018-08-20
10381780488262Integra® Miltex®MH30-15MH30-152018-08-20
10381780488279Integra® Miltex®MH30-20MH30-202018-08-20
10381780488286Integra® Miltex®MH30-30MH30-302018-08-20
10381780488293Integra® Miltex®MH30-50MH30-502018-08-20
10381780488361Integra® Miltex®MH30-55MH30-552018-08-20
10381780488378Integra® Miltex®MH30-60MH30-602018-08-20
10381780488385Integra® Miltex®MH30-62MH30-622018-08-20
10381780500490Integra® Miltex®30-1030-102018-09-18
10381780500520Integra® Miltex®30-1530-152018-09-18
10381780500605Integra® Miltex®30-2030-202018-09-18
10381780077244Integra®371231037123102018-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04054462906680evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906697evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906703evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906710evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906727evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906734evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906765evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906772evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906796evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906826evonosevonos GmbH & Co. KGJYL2026-08-21
04054462907069evonosevonos GmbH & Co. KGJYL2026-08-21
04054462907113evonosevonos GmbH & Co. KGJYL2026-08-21
04054462907274evonosevonos GmbH & Co. KGJYL2026-08-21
04054462907335evonosevonos GmbH & Co. KGJYL2026-08-21
04054462911585evonosevonos GmbH & Co. KGJYL2026-08-19
04054462901524evonosevonos GmbH & Co. KGJYL2026-08-18
04054462901531evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906741evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906758evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906789evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906802evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906925evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906932evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906949evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906956evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906963evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906970evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906987evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906994evonosevonos GmbH & Co. KGJYL2026-08-18
04054462907007evonosevonos GmbH & Co. KGJYL2026-08-18