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
10381780191070Integra® Jarit®400293400-2932018-04-02
10381780193180Integra® Jarit®P408P4082018-04-02
10381780197997Integra® Jarit®380232380-2322017-09-29
10381780198000Integra® Jarit®380233380-2332018-03-22
10381780198543Integra® Jarit®385295385-2952018-03-22
10381780220121Integra® Jarit®P666P6662018-01-31
10381780390381Integra® Jarit®380230380-2302018-02-16
10381780390398Integra® Jarit®380231380-2312018-02-16
10381780456469Integra® Jarit®405225405-2252018-01-31
10381780457190Integra® Jarit®P667P6672018-01-31
10381780458159Integra® Jarit®385315385-3152018-03-01
10381780458166Integra® Jarit®385316385-3162018-03-01
10381780487708Integra® Miltex®MH21-300MH21-3002018-08-22
10381780503910Integra® Miltex®PM-666PM-6662020-10-01
10381780520665CereLink™82684582-68452020-04-01
10381780087984Integra®375001237500122018-10-26
10381780081371Integra®372201137220112018-10-24
10381780081388Integra®372201237220122018-10-24
10381780081906Integra®372206937220692018-10-24
10381780081913Integra®372207037220702018-10-24

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