FDA.reportPublic FDA data

Integra®

Primary DI
10381780090977
Brand
Integra®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
9610200
Catalog number
9610200
Device description
Integra® OroTracheal Injection Instrument with Angled Cannula
Published
2018-10-26
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
FGYCANNULA, INJECTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGYCannula, InjectionGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780090977PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178009097710381780090977

GMDN Terms#

Term, Definition table
TermDefinition
Syringe-loaded injector, manual, professionalA hand-held, manually-powered mechanical device intended to be used in conjunction with a standard plunger syringe and needle to administer an injection of medication or vaccine to a patient intramuscularly (IM) or subcutaneously. The delivered medication/vaccine is supplied from the prefilled syringe that is loaded into the injector, which is typically a spring-loaded mechanical assembly. It is intended for use by a healthcare professional when serial injections are provided (e.g., mass inoculation); it is not a hypodermic syringe. 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
Kit
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
00381780363883Miltex®62509625092017-01-05
10381780160373Integra® Miltex®24300024-30002016-08-03
10381780160380Integra® Miltex®24301024-30102016-08-03
10381780160397Integra® Miltex®24302024-30202016-08-03
10381780358831Integra® Miltex®11-24211-2422017-06-28
10381780358848Integra® Miltex®11-24411-2442017-06-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810192690701CerosRhino Medical Supply IncFGY2025-11-18
00810192690718CerosRhino Medical Supply IncFGY2025-11-18
00850041572994CerosRhino Medical Supply IncFGY2024-03-19
00866497000301ClearVu 2.7 BluntCannuflow, Inc.FGY2024-01-16
00866497000318ClearVu 2.7 SharpCannuflow, Inc.FGY2024-01-16
00866497000325EntreVuCannuflow, Inc.FGY2024-01-16
00866497000332ExtravaStopperCannuflow, Inc.FGY2024-01-16
00866497000349TwoVuCannuflow, Inc.FGY2024-01-16
00866497000356TwoVuCannuflow, Inc.FGY2024-01-16
00866497000363TwoVuCannuflow, Inc.FGY2024-01-16
00866497000370TwoVuCannuflow, Inc.FGY2024-01-16
20866497000305ClearVu 2.7 BluntCannuflow, Inc.FGY2024-01-16
20866497000312ClearVu 2.7 SharpCannuflow, Inc.FGY2024-01-16
20866497000329EntreVuCannuflow, Inc.FGY2024-01-16
20866497000336ExtravaStopperCannuflow, Inc.FGY2024-01-16
20866497000343TwoVuCannuflow, Inc.FGY2024-01-16
20866497000350TwoVuCannuflow, Inc.FGY2024-01-16
20866497000367TwoVuCannuflow, Inc.FGY2024-01-16
20866497000374TwoVuCannuflow, Inc.FGY2024-01-16
00850023741875CER-SUB-1590RANFAC CORP.FGY2023-12-13
00614950029976ACEACE SURGICAL SUPPLY CO., INC.FGY2023-12-05
00614950029983ACEACE SURGICAL SUPPLY CO., INC.FGY2023-12-05
00190776308025MillenniumAvalign Technologies, Inc.FGY2023-06-23
06936841208098IV cannulaTianck Medical Co., Ltd.FGY2023-02-06
06971162812197IV cannulaTianck Medical Co., Ltd.FGY2023-02-06
06971162812203IV cannulaTianck Medical Co., Ltd.FGY2023-02-06
06971162812210IV cannulaTianck Medical Co., Ltd.FGY2023-02-06
06971162812227IV cannulaTianck Medical Co., Ltd.FGY2023-02-06
06971162812234IV cannulaTianck Medical Co., Ltd.FGY2023-02-06
06971162816843IV cannulaTianck Medical Co., Ltd.FGY2023-02-06