Integra

Primary DI
M610310461
Brand
Integra
Company
INTEGRA PAIN MANAGEMENT
Model
31046
Device description
Combo Kit Consists OF SP0098/INS-4500
Published
2016-12-29
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
10381780178118PrimaryGS10
M610310461SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178017811810381780178118

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
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
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
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