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
OTC
false
Sterile
false
Single use
false

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-accepting percutaneous/submucosal fluid injector, manual, professionalA hand-held, manually-powered mechanical device intended for use by a healthcare professional to accept a syringe (not included) for administering a percutaneous (e.g., intramuscular, subcutaneous) and/or submucosal injection of a medical fluid (e.g., medication, vaccine) to a patient; it is not dedicated to dental or intravenous applications. The device is typically a spring-loaded mechanical assembly in the form of a pistol or cylinder; the pharmaceutical is not included. 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
true
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
10381780541585CODMAN® ACCU-FLO®82620282-62022024-05-29
10381780541738CODMAN®82304882-30482024-05-29
10381780536918CODMAN® ACCU-FLO®82152082-15202024-05-29
10381780536925CODMAN® ACCU-FLO®82152182-15212024-05-29
10381780537373CODMAN®82409582-40952024-05-29
10381780537380CODMAN®82859182-85912024-05-29
10381780541578CODMAN® ACCU-FLO®82620182-62012024-05-29
10381780541745CODMAN®82304982-30492024-05-29
10381780075073Integra®165002516500252018-09-17
10381780075080Integra®165003016500302018-09-17
10381780075097Integra®165005016500502018-09-17
10381780518525CODMAN® HAKIM®82300782-30072020-06-02
10381780518532CODMAN® HAKIM®82300882-30082020-06-02
10381780518600CODMAN® HAKIM®82301582-30152020-06-02
10381780518716CODMAN® HAKIM®82302682-30262020-06-02
10381780518761CODMAN® HAKIM®82303582-30352020-06-02
10381780518808CODMAN® HAKIM®82303982-30392020-06-02
10381780518976CODMAN® HAKIM®82308282-30822020-06-02
10381780519010CODMAN® HAKIM®82308682-30862020-06-02
10381780519089CODMAN® HAKIM®82309782-30972020-06-02

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