Large Bone Blades

GUDID 08404535013108

KM-250S5R

Peter Brasseler Holdings, LLC

Surgical saw blade, reciprocating, single-use
Primary Device ID08404535013108
NIH Device Record Key55f24f03-2868-4425-ad70-0aa69bd86e6a
Commercial Distribution StatusIn Commercial Distribution
Brand NameLarge Bone Blades
Version Model NumberKM-250S5R
Company DUNS082080136
Company NamePeter Brasseler Holdings, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108404535013108 [Primary]

FDA Product Code

GFABLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[08404535013108]

Radiation Sterilization


[08404535013108]

Radiation Sterilization


[08404535013108]

Radiation Sterilization


[08404535013108]

Radiation Sterilization


[08404535013108]

Radiation Sterilization


[08404535013108]

Radiation Sterilization


[08404535013108]

Radiation Sterilization


[08404535013108]

Radiation Sterilization


[08404535013108]

Radiation Sterilization


[08404535013108]

Radiation Sterilization


[08404535013108]

Radiation Sterilization


[08404535013108]

Radiation Sterilization


[08404535013108]

Radiation Sterilization


[08404535013108]

Radiation Sterilization


[08404535013108]

Radiation Sterilization


[08404535013108]

Radiation Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-12
Device Publish Date2025-03-04

On-Brand Devices [Large Bone Blades]

08404535013139KM-251R
08404535013108KM-250S5R

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