FDA.reportPublic FDA data

NA

Primary DI
04546540274250
Brand
NA
Company
Stryker Leibinger GmbH & Co. KG
Model
64-00132
Catalog number
64-00132
Device description
MESH BENDING PLIERS
Published
2017-01-11
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
false

Product Codes#

Code, Name table
CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540274250PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540274250045465402742504546540274250

GMDN Terms#

Term, Definition table
TermDefinition
Bone fixation plate pliersA manual surgical instrument designed to bend and cut light-bone fixation plates (e.g., 1 to 2 mm in thickness), such as those used in craniomaxillofacial (CMF) or finger surgery. The instrument is typically made of high-grade steel and consists of two arms/rods that form a handle proximally and extend distally through a pivot to form jaws that bend and cut the metal plates allowing the surgeon to customize their size and shape. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
316153956
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327300086NA78-8002078-800202021-01-27
07613327300109NA78-8004078-800402021-01-27
07613327300123NA78-8003078-800302021-01-27
04546540730763NA78-1001078-100102015-07-03
04546540730787NA78-1003078-100302015-07-03
04546540730794NA78-1004078-100402015-07-03
04546540730800NA78-1010078-101002015-07-03
07613327004021NA78-1002078-100202015-07-03
07613327129236NA78-4001078-400102015-09-24
07613327129243NA78-4010078-401002015-09-24
07613327129250NA78-4004078-400402015-09-24
07613327129267NA78-5003078-500302015-09-24
07613327129274NA78-5004078-500402015-09-24
07613327129281NA78-5002078-500202015-09-24
07613327129298NA78-4003078-400302015-09-24
07613327129328NA78-5001078-500102015-09-24
07613327129335NA78-4002078-400202015-09-24
07613327300017NA78-7002078-700202017-02-21
07613327300031NA78-7004078-700402017-02-21
07613327300055NA78-7003078-700302017-02-21

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