GUDID 00850005084716

Ø4.0mm Carbide Drill Bit 50mm OAL, Left Hand

PACIFIC INSTRUMENTS, INC.

Orthopaedic bur, reusable
Primary Device ID00850005084716
NIH Device Record Key444ff21b-9582-4ce1-a070-7a07e138e3dc
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberPI-2640
Company DUNS621872006
Company NamePACIFIC INSTRUMENTS, INC.
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850005084716 [Primary]

FDA Product Code

HTWBit, Drill

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850005084716]

Moist Heat or Steam Sterilization


[00850005084716]

Moist Heat or Steam Sterilization


[00850005084716]

Moist Heat or Steam Sterilization


[00850005084716]

Moist Heat or Steam Sterilization


[00850005084716]

Moist Heat or Steam Sterilization


[00850005084716]

Moist Heat or Steam Sterilization


[00850005084716]

Moist Heat or Steam Sterilization


[00850005084716]

Moist Heat or Steam Sterilization


[00850005084716]

Moist Heat or Steam Sterilization


[00850005084716]

Moist Heat or Steam Sterilization


[00850005084716]

Moist Heat or Steam Sterilization


[00850005084716]

Moist Heat or Steam Sterilization


[00850005084716]

Moist Heat or Steam Sterilization


[00850005084716]

Moist Heat or Steam Sterilization


[00850005084716]

Moist Heat or Steam Sterilization


[00850005084716]

Moist Heat or Steam Sterilization


[00850005084716]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-06
Device Publish Date2024-07-29

Devices Manufactured by PACIFIC INSTRUMENTS, INC.

00850005084921 - NA2024-11-14 TBD
00850005084723 - NA2024-10-08 Ø4.0mm Carbide Drill Bit 75 mm OAL, Left Hand
00850005084914 - NA2024-10-04 T Grip 116, OAL 91.4mm, Big AO QC, Cannulated
00850005084907 - NA2024-09-06 Palm Grip 040, OAL 90mm, 1/4" QC, Ratcheting, Cannulated
00850005084709 - NA2024-08-14 Conical Extraction Screw for 4.5/5.0/6.5/7.0mmm Screws
00850005084846 - NA2024-08-09 Small Wide Hohmann Retractor
00850005084853 - NA2024-08-09 Large Wide Hohmann Retractor
00850005084860 - NA2024-08-09 Medium Femoral Retractor

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