FDA.reportPublic FDA data

Integra®

Primary DI
10381780262831
Brand
Integra®
Company
INTEGRA PAIN MANAGEMENT
Model
CUS1288-02
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
30381780262835PackageGS110Not in Commercial Distribution
30381780430821PackageGS110In Commercial Distribution
10381780262831PreviousGS10
10381780430827PrimaryGS10
M610CUS1288021SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3038178026283530381780262835
3038178043082130381780430821
1038178026283110381780262831
1038178043082710381780430827

GMDN Terms#

Term, Definition table
TermDefinition
Epidural anaesthesia set, medicatedA collection of devices intended for the administration of an analgesic or anaesthetic agent to the epidural space for the management of pain. It includes the pharmaceutical anaesthetic agent and a needle, with additional devices utilized for the procedure (e.g., syringe, dressings), and may include a catheter (i.e., may be intended for single- or continuous-administration). It is not intended for intrathetcal anaesthesia. 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
10381780261247Integra®INTEGRA PAIN MANAGEMENTIZG2016-09-16
10381780262824Integra®INTEGRA PAIN MANAGEMENTIZG2016-09-16