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
10381780406914Integra® Jarit®X312143X3121432018-05-03
10381780421245Integra® Miltex®20-103220-10322017-12-21
10381780076155Integra®371106837110682018-09-17
10381780076162Integra®371106937110692018-09-17
10381780076179Integra®371107137110712018-09-17
10381780533276Codman®901001BRKT901001BRKT2026-10-15
10381780533283Codman®901001POLC901001POLC2026-10-15
10381780129103Integra® Jarit®615296B615-296B2016-08-11
10381780146025Integra® Jarit®600CTVA600-CTVA2016-08-24
10381780146032Integra® Jarit®600SCR138600-SCR-1382016-08-24
10381780146049Integra® Jarit®600SPR138600-SPR-1382016-08-24
10381780146056Integra® Jarit®600SPS550600-SPS-5502016-08-24
10381780146698Integra® Jarit®610107DA610-107DA2016-08-24
10381780147053Integra® Jarit®625107RD625-107RD2016-08-24
10381780147404Integra® Jarit®630107IL630-107IL2016-08-24
10381780147541Integra® Jarit®632107IL632-107IL2016-08-24
10381780152866Integra® Ruggles®-Redmond™R6312R63122016-08-11
10381780152873Integra® Ruggles®-Redmond™R8974R89742016-08-11
10381780152880Integra® Ruggles®-Redmond™R8978R89782016-08-11
10381780154495Integra® Ruggles®-Redmond™R2381R23812016-08-11

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