FDA.report

NA

Primary DI
07613153171164
Brand
NA
Company
Stryker Leibinger GmbH & Co. KG
Model
92-12172
Catalog number
92-12172
Device description
TENSION PLIERS 1.2MM, MID-FACE
Published
2016-10-19
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

Related Records

Product Codes

CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07613153171164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07613153171164076131531711647613153171164

GMDN Terms

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

TypeValueUnit
Length4Centimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

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

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