FDA.report

Saw Blade

Primary DI
24053613284978
Company
Gebr. Brasseler GmbH & Co. KG
Model
5109-098-043
Catalog number
5109-098-043
Device description
Reciprocating saw blade
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

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

Identifiers

IdentifierTypeAgencyPackage quantityStatus
24053613284978PackageGS11In Commercial Distribution
14053613284971PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
24053613284978PackageGS1114053613284971In Commercial Distribution
14053613284971PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
GFABlade, Saw, General & Plastic Surgery, Surgical1General, Plastic Surgery878.4820NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Surgical saw blade, reciprocating, single-useA sterile, 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 dedicated sternum saw blade). This device is designed with the cutting teeth arranged in a straight line along the cutting edge and which cuts when the blade is powered in a rapid reciprocating movement (a back and forth motion like a jigsaw) against the object to be cut. The end of the blade is typically not protected. This is a single-use device.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

No records found.

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24053613295936Bur, Round, round shank08226790082267902026-03-11
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24053613296803Bur, Round, round shank08227750082277502026-03-11
24053613297121Bur, cylindrical, round shank08228070082280702026-03-11
24053613297190Bur, Egg / egg shaped, round shank08228140082281402026-03-11
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E226007158R18KOMET Root Canal Files17321.654.006.R117321.654.0062025-12-10
E226007159R18KOMET Root Canal Files17321.654.008.R117321.654.0082025-12-10

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