GUDID 00850005084679

Lamina Distractor

PACIFIC INSTRUMENTS, INC.

Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal
Primary Device ID00850005084679
NIH Device Record Keyb6131c0e-d8d8-4251-8402-58a01228f3dc
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberPI-3695
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
GS100850005084679 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850005084679]

Moist Heat or Steam Sterilization


[00850005084679]

Moist Heat or Steam Sterilization


[00850005084679]

Moist Heat or Steam Sterilization


[00850005084679]

Moist Heat or Steam Sterilization


[00850005084679]

Moist Heat or Steam Sterilization


[00850005084679]

Moist Heat or Steam Sterilization


[00850005084679]

Moist Heat or Steam Sterilization


[00850005084679]

Moist Heat or Steam Sterilization


[00850005084679]

Moist Heat or Steam Sterilization


[00850005084679]

Moist Heat or Steam Sterilization


[00850005084679]

Moist Heat or Steam Sterilization


[00850005084679]

Moist Heat or Steam Sterilization


[00850005084679]

Moist Heat or Steam Sterilization


[00850005084679]

Moist Heat or Steam Sterilization


[00850005084679]

Moist Heat or Steam Sterilization


[00850005084679]

Moist Heat or Steam Sterilization


[00850005084679]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-27
Device Publish Date2024-03-19

Devices Manufactured by PACIFIC INSTRUMENTS, INC.

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00850005084686 - NA2024-03-28 8x11mm Cup Curette, Angled Up
00850005084679 - NA2024-03-27Lamina Distractor
00850005084679 - NA2024-03-27 Lamina Distractor
00850005084082 - NA2024-03-26 Plate Bending Pliers for Forearm Plate
00850005084662 - Pacific Instruments2024-03-19 ALIF Distractor
00850005084655 - Pacific Instruments2024-02-29 ALIF Distractor
00850005084549 - Pacific Instruments2024-02-26 6x10mm Cup Curette, Straight, 449mm OAL

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