TWIST DRILLS

GUDID 00887919091721

KM166-310-37S

Peter Brasseler Holdings, LLC

Fluted surgical drill bit, single-use
Primary Device ID00887919091721
NIH Device Record Key1013bc74-3b87-43da-9f0c-9b0f45495b2e
Commercial Distribution StatusIn Commercial Distribution
Brand NameTWIST DRILLS
Version Model NumberKM166-310-37S
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
GS100887919091721 [Primary]

FDA Product Code

GFFBUR, SURGICAL, GENERAL & PLASTIC SURGERY

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00887919091721]

Radiation Sterilization


[00887919091721]

Radiation Sterilization


[00887919091721]

Radiation Sterilization


[00887919091721]

Radiation Sterilization


[00887919091721]

Radiation Sterilization


[00887919091721]

Radiation Sterilization


[00887919091721]

Radiation Sterilization


[00887919091721]

Radiation Sterilization


[00887919091721]

Radiation Sterilization


[00887919091721]

Radiation Sterilization


[00887919091721]

Radiation Sterilization


[00887919091721]

Radiation Sterilization


[00887919091721]

Radiation Sterilization


[00887919091721]

Radiation Sterilization


[00887919091721]

Radiation Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-28
Device Publish Date2025-03-20

On-Brand Devices [TWIST DRILLS]

00887919091622KM166-310-25S
00887919091721KM166-310-37S
00887919091608KM166-310-23S

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