FDA.report

NA

Primary DI
34546540134739
Brand
NA
Company
Stryker Leibinger GmbH & Co. KG
Model
01-03104
Catalog number
01-03104
Device description
LIGATURE WIRES
Published
2015-07-06
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

Related Records

Product Codes

CodeName
JEYPLATE, BONE

Product Code Classifications

CodeDeviceSpecialtyClass
JEYPlate, BoneDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
34546540134739PrimaryGS10
04546540134738Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3454654013473934546540134739
04546540134738045465401347384546540134738

GMDN Terms

TermDefinition
Craniofacial bone wire/barA length of metal (e.g., stainless steel) intended to stabilize bony fragments (fractured bone) in the oral cavity and/or stabilize injured teeth. Stabilization occurs by direct application of the device to the bone/teeth (e.g., by wrapping the ligature around fractured bone segments and locking the ends together). The device may be used for intermaxillary fixation, maxillomandibular fixation, or other forms of jaw immobilization. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Length30Centimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
316153956
Device count
10
DM exempt
false
Premarket exempt
false
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

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