Integra®

Primary DI
30381780263894
Brand
Integra®
Company
INTEGRA PAIN MANAGEMENT
Model
INS030
Catalog number
INS030
Device description
HAND DRILL - STERILE
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
30381780263894PackageGS110In Commercial Distribution
10381780263890PrimaryGS10
M610INS0301SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3038178026389430381780263894
1038178026389010381780263890

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.

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
false
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
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