FDA.reportPublic FDA data

Sawblade EZ

Primary DI
04053613068291
Brand
Sawblade EZ
Company
Gebr. Brasseler GmbH & Co. KG
Model
54780088
Catalog number
54780088
Device description
Sawblade EZ for Aesculap® Acculan® 90,00 x 19,05 x 1,37 (x 1,37)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

Product Codes#

Code, Name table
CodeName
GFABlade, Saw, General & Plastic Surgery, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFABlade, Saw, General & Plastic Surgery, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04053613068291Direct MarkingGS10
24053613068295PackageGS11In Commercial Distribution
14053613068298PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04053613068291040536130682914053613068291
2405361306829524053613068295
1405361306829814053613068298

GMDN Terms#

Term, Definition table
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 table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
24053613265496Steinmann PinSP-80005-00-00SP-80005-00-002026-03-20
24053613296209Bur, tapered, round shank08227100082271002026-03-20
24053613295929Bur, Round, round shank08226780082267802026-03-11
24053613295936Bur, Round, round shank08226790082267902026-03-11
24053613296131Bur, Round, round shank08227000082270002026-03-11
24053613296193Bur, tapered, round shank08227090082270902026-03-11
24053613296803Bur, Round, round shank08227750082277502026-03-11
24053613297121Bur, cylindrical, round shank08228070082280702026-03-11
24053613297190Bur, Egg / egg shaped, round shank08228140082281402026-03-11
24053613297206Bur, Egg / egg shaped, round shank08228150082281502026-03-11
24053613297220Bur, Round, round shank08228170082281702026-03-11
04053613298315Guide Pin Smooth800-05-215800-05-2152026-03-11
84053613294535Guide Pin Smooth800-05-215800-05-2152026-01-30
24053613295721Shannon Recta X-LargaG01 S5330G01 S53302026-01-23
24053613284978Saw Blade5109-098-0435109-098-0432022-12-08
E226048483R18KOMET Root Canal Files17331.654.012.R117331.654.0122026-01-13
14053613294581Tech Ancillary Pack150-00-002150-00-0022026-01-08
24053613294557Guide Drill Pin800-02-508800-02-5082026-01-06
14053613294574Tech Knee Pack150-00-001150-00-0012026-01-06
E226007158R18KOMET Root Canal Files17321.654.006.R117321.654.0062025-12-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867614956Arthrex®ARTHREX, INC.GFA2026-05-25
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B504OMDC119090180Conmed LinvatecProvisionGFA2026-03-19
00810111225366Saw BladeTreace Medical Concepts, Inc.GFA2026-01-26
00810111225342Saw BladeTreace Medical Concepts, Inc.GFA2026-01-07
00810111225335Saw BladeTreace Medical Concepts, Inc.GFA2025-12-18
08681506801180SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETIGFA2025-12-12
B39062901120331Reprocessed 3mm Straight Shaver BladeSURETEK MEDICALGFA2025-12-09
B3906290112040121Reprocessed 4mm Angled 12 Degree Shaver BladeSURETEK MEDICALGFA2025-12-09
B3906290112040601Reprocessed 4mm Angled 60 Degree Shaver BladeSURETEK MEDICALGFA2025-12-09
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