FDA.report

Sawblade EZ

Primary DI
04053613063869
Brand
Sawblade EZ
Company
Gebr. Brasseler GmbH & Co. KG
Model
54780062
Catalog number
54780062
Device description
Sawblade EZ for Aesculap® 90,00 x 22,00 x 1,27 (x 1,27)mm
Published
2022-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Related Records

Product Codes

CodeName
GFABlade, Saw, General & Plastic Surgery, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
GFABlade, Saw, General & Plastic Surgery, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04053613063869Direct MarkingGS10
24053613063863PackageGS11In Commercial Distribution
14053613063866PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04053613063869040536130638694053613063869
2405361306386324053613063863
1405361306386614053613063866

GMDN Terms

TermDefinition
Surgical saw blade, sagittal, reusableA flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery; it is not dedicated to cutting through the sternum (i.e., not a sternum saw blade). This device is designed with the cutting teeth arranged in an arc or on a flat plane pointing directly forward at the distal end to cut in a rapid sagittal (side to side) motion; it may in addition cut in an oscillating motion. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
317409001
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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24053613295936Bur, Round, round shank08226790082267902026-03-11
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24053613297121Bur, cylindrical, round shank08228070082280702026-03-11
24053613297190Bur, Egg / egg shaped, round shank08228140082281402026-03-11
24053613297206Bur, Egg / egg shaped, round shank08228150082281502026-03-11
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