Integra®

Primary DI
30381780265362
Brand
Integra®
Company
INTEGRA PAIN MANAGEMENT
Model
3404937
Device description
SINGLE SHOT EPIDURAL TRAY
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30381780265362PackageGS120In Commercial Distribution
10381780265368PrimaryGS10
M61034049371SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3038178026536230381780265362
1038178026536810381780265368

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, Specify00Storage Environment Temperature: 20 C to 25 C (68 F to 77 F)

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
030370299
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30381780263917Integra®INS70402016-09-16
30381780263924Integra®INS72502016-09-16
30381780263931Integra®INS72602016-09-16
30381780263948Integra®INS72702016-09-16
30381780263955Integra®INS72802016-09-16
30381780544382Integra®HITHSP04HITHSP042025-08-20
30381780544399Integra®HITHSP06HITHSP062025-08-20
M610310041Integra310042016-12-29
M610310461Integra310462016-12-29
M610310811Integra310812016-12-29
M610311081Integra311082016-12-29
M610311271Integra311272016-12-29
M610311321Integra311322016-12-29
M610311561Integra311562016-12-29
M610312041Integra312042016-12-29
M610105601Integra®10-5602016-09-30
10381780537304Integra®INS5HNDINS5HND2024-11-19
10381780263890Integra®INS030INS0302024-11-19
10381780537328Integra®SP0075SP00752024-11-19
10381780537335Integra®SP0087SP00872024-11-19