Integra®

Primary DI
30381780264808
Brand
Integra®
Company
INTEGRA PAIN MANAGEMENT
Model
SP0098
Catalog number
SP0098
Device description
CRANIAL DRILL PROCEDURE KIT
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
false
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30381780264808PackageGS14In Commercial Distribution
10381780264804PrimaryGS10
M610SP00981SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3038178026480830381780264808
1038178026480410381780264804

GMDN Terms#

Term, Definition table
TermDefinition
Manual cranial rotary handpiece, single-useA manually-powered, hand-held, surgical device intended to be used to remove circular sections of the skull vault (calvarium) to provide access to the interior for diagnosis (e.g., the insertion of a neuroscope), or treatments [e.g., to alleviate intracranial pressure (ICP)], or for the removal of a bone flap for brain surgery. It is typically a drill brace or a housing containing bevelled and/or straight teethed gears rotated via a side handle, and a Jacobs chuck or gripping collet to attach an exchangeable rotating endpiece (e.g., a cranial drill, bur, trephine or perforator). 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
false
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