Integra®

Primary DI
30381780422697
Brand
Integra®
Company
INTEGRA PAIN MANAGEMENT
Model
3405278
Device description
Lumbar ILESI Tray
Published
2017-05-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30381780422697PackageGS120Not in Commercial Distribution
10381780422693PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3038178042269730381780422697
1038178042269310381780422693

GMDN Terms

TermDefinition
Lumbar puncture kitA collection of sterile devices designed to perform a puncture of the lumbar spine to obtain spinal fluid. Typical components include a spinal needle and collection tubes for spinal fluid. This is a single-use device.

Storage And Handling

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

Sterilization Methods

Method

Contacts

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
false
Sterilization required before use
false

Other Devices From This Company

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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