FDA.reportPublic FDA data

Integra®

Primary DI
10381780261247
Brand
Integra®
Company
INTEGRA PAIN MANAGEMENT
Model
3403970
Device description
DISCOGRAM TRAY
Published
2016-09-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IZGSystem, x-ray, photofluorographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZGSystem, X-Ray, PhotofluorographicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K960082000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K960082000DISCOGRAPHY KITSpinal Specialties, Inc.1996-03-21IZG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30381780261241PackageGS110Not in Commercial Distribution
30381780430043PackageGS110In Commercial Distribution
10381780261247PreviousGS10
10381780430049PrimaryGS10
M61034039701SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3038178026124130381780261241
3038178043004330381780430043
1038178026124710381780261247
1038178043004910381780430049

GMDN Terms#

Term, Definition table
TermDefinition
Interventional radiology percutaneous-access procedure kitA collection of various sterile radiopaque instruments/devices (e.g., introducer sheath, dilator, needle, angiographic catheter) intended to be used for image-guided, single-puncture, percutaneous access to facilitate an interventional radiology procedure (e.g., bile duct biopsy, percutaneous transhepatic cholangiogram, non-vascular drainage procedures). It does not contain pharmaceuticals. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do Not Use if Package is Damaged
Special Storage Condition, Specify00Storage Environment Temperature: 20 C to 25 C (68 F to 77 F)
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature68 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
030370299
Device count
1
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780260356Integra®10-5602016-09-30
10381780263913Integra®INS70402016-09-16
10381780263920Integra®INS72502016-09-16
10381780263937Integra®INS72602016-09-16
10381780263944Integra®INS72702016-09-16
10381780263951Integra®INS72802016-09-16
30381780263917Integra®INS70402016-09-16
30381780263924Integra®INS72502016-09-16
30381780263931Integra®INS72602016-09-16
30381780263948Integra®INS72702016-09-16
30381780263955Integra®INS72802016-09-16
10381780355892Integra®31254312542016-12-20
10381780544388Integra®HITHSP04HITHSP042025-08-20
10381780544395Integra®HITHSP06HITHSP062025-08-20
30381780544382Integra®HITHSP04HITHSP042025-08-20
30381780544399Integra®HITHSP06HITHSP062025-08-20
10381780178095Integra310042016-12-29
10381780178118Integra310462016-12-29
10381780178125Integra310812016-12-29
10381780178170Integra311082016-12-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10381780430049Integra®INTEGRA PAIN MANAGEMENTIZG2018-06-20
10381780430810Integra®INTEGRA PAIN MANAGEMENTIZG2018-06-20
10381780430827Integra®INTEGRA PAIN MANAGEMENTIZG2018-06-20
10381780262824Integra®INTEGRA PAIN MANAGEMENTIZG2016-09-16
10381780262831Integra®INTEGRA PAIN MANAGEMENTIZG2016-09-16