FDA.reportPublic FDA data

Integra®

Primary DI
10381780431770
Brand
Integra®
Company
INTEGRA PAIN MANAGEMENT
Model
3405147
Catalog number
3405147
Device description
Epidural Pain Tray
Published
2018-06-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAZAnesthesia conduction kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAZAnesthesia Conduction KitAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K945484000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K945484000PIDURAL STEROID SYSTEMProfessional Medical Device Consultants1995-06-02CAZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30381780431774PackageGS110Not in Commercial Distribution
10381780431770PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3038178043177430381780431774
1038178043177010381780431770

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
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature68 Degrees Fahrenheit77 Degrees Fahrenheit

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
10193489490312Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAZ2022-08-04
10193489031768MedlineMEDLINE INDUSTRIES, INC.CAZ2022-03-04
10193489031775MedlineMEDLINE INDUSTRIES, INC.CAZ2022-03-04
10193489031782MedlineMEDLINE INDUSTRIES, INC.CAZ2022-03-04
10193489031799MedlineMEDLINE INDUSTRIES, INC.CAZ2022-03-04
10381780529071Integra®INTEGRA PAIN MANAGEMENTCAZ2019-10-24
10381780527633Integra®INTEGRA PAIN MANAGEMENTCAZ2019-07-16
10381780527404Integra®INTEGRA PAIN MANAGEMENTCAZ2019-05-13
10381780527015Integra®INTEGRA PAIN MANAGEMENTCAZ2019-03-05
10381780511465Integra®INTEGRA PAIN MANAGEMENTCAZ2019-02-27
10381780511281Integra®INTEGRA PAIN MANAGEMENTCAZ2019-01-18
10381780491316Integra®INTEGRA PAIN MANAGEMENTCAZ2018-08-16
10381780464792Integra®INTEGRA PAIN MANAGEMENTCAZ2018-07-16
10381780429531Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22
10381780431640Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22
10381780431657Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22
10381780431749Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22
10381780431763Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22
10381780466611Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22
10381780486756Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22
10381780486763Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22
10381780429487Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-20
10381780429494Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-20
10381780429524Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-20
10381780429562Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-20
10381780429586Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-20
10381780429593Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-20
10381780429609Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-20
10381780429616Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-20
10381780429623Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-20