FDA.reportPublic FDA data

Integra®

Primary DI
10381780086246
Brand
Integra®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
3734114
Catalog number
3734114
Device description
Integra® Laryngeal Handle
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
JZYKNIFE, LARYNGEAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZYKnife, LaryngealEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780086246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178008624610381780086246

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel handle, reusableA device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Width20Millimeter

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
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
00190776228200AvalignAvalign Technologies, Inc.JZY2023-09-28
00190776228217AvalignAvalign Technologies, Inc.JZY2023-09-28
00190776328061MILLENNIUMAvalign Technologies, Inc.JZY2023-09-28
04055207039137NARichard Wolf GmbHJZY2022-08-09
04055207039144NARichard Wolf GmbHJZY2022-08-09
04055207039151NARichard Wolf GmbHJZY2022-08-09
04055207039168NARichard Wolf GmbHJZY2022-08-09
00190776050191AvalignAvalign Technologies, Inc.JZY2021-11-03
00190660093402Ambler SurgicalAMBLER SURGICAL CORP.JZY2021-01-07
00190660093419Ambler SurgicalAMBLER SURGICAL CORP.JZY2021-01-07
00190660093426Ambler SurgicalAMBLER SURGICAL CORP.JZY2021-01-07
00190660093433Ambler SurgicalAMBLER SURGICAL CORP.JZY2021-01-07
04046826136338MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZY2020-09-24
04046826136369MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZY2020-09-24
04046826136376MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZY2020-09-24
04046826136345MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZY2020-09-24
M6334281900JEDMEDJEDMED INSTRUMENT COMPANYJZY2020-09-01
M6334282120JEDMEDJEDMED INSTRUMENT COMPANYJZY2020-09-01
M63342821210JEDMEDJEDMED INSTRUMENT COMPANYJZY2020-09-01
M6334282140JEDMEDJEDMED INSTRUMENT COMPANYJZY2020-09-01
M6334282160JEDMEDJEDMED INSTRUMENT COMPANYJZY2020-09-01
M6334282180JEDMEDJEDMED INSTRUMENT COMPANYJZY2020-09-01
M6334282200JEDMEDJEDMED INSTRUMENT COMPANYJZY2020-09-01
04038653180622AESCULAPAesculap AGJZY2020-06-17
04038653053964AESCULAPAesculap AGJZY2020-04-20
10381780090984Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZY2018-10-26
10381780086260Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZY2018-10-24
10381780086291Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZY2018-10-24
10381780086307Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZY2018-10-24
10381780074946Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZY2018-09-17