FDA.reportPublic FDA data

LARGE UNI-CLIP®

Primary DI
10381780051930
Brand
LARGE UNI-CLIP®
Company
NEWDEAL
Model
119322ND
Device description
The straight drilling guide, positionned with the osteotomy centered between the two sleeves, is used to guide the drills while drilling the holes for the straight staples.
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXJSTAPLE DRIVER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXJStaple DriverOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780051930PrimaryGS10
M248119322ND1SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178005193010381780051930

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
536935331
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

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10381780042426IPP-ON®239001ND2017-05-26
10381780042778PANTA®519920ND2017-05-26
10381780042822SURFIX®SET000ND2017-05-26
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10381780052036SURFIX®MA003ND2017-05-26
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10381780126539TIBIAXYS®159985ND2017-05-26
10381780044574PANTA XL510004ND510004ND2017-10-09

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Primary DI, Brand, Company table
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06438408007293Inion FreedomPin InstrumentsInion OyHXJ2020-05-08
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M224INS92889Inion FreedomPin InstrumentsInion OyHXJ2020-05-08
M224INS92309Inion OTPS Pin InstrumentsInion OyHXJ2020-05-08
M224INS92319Inion OTPS Pin InstrumentsInion OyHXJ2020-05-08
M224INS928020Inion FreedomPin InstrumentsInion OyHXJ2020-05-08
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