Spurling Pitutiary Ronguer 4mm/18cm 08-007-18

GUDID G25008007180

A hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (intervertebral disk) or bone, through a cutting/biting action, during open spinal surgery (e.g., laminectomy, discectomy). It is typically made of metal and designed to withstand the forces required to bite over tough tissue. It is not intended for endoscopic access. This is a reusable device.

N S SURGICAL COMPANY

Spinal rongeur
Primary Device IDG25008007180
NIH Device Record Key041172ae-dadf-4e6a-9253-a513266ce7dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpurling Pitutiary Ronguer 4mm/18cm
Version Model Number08-007-18
Catalog Number08-007-18
Company DUNS645681649
Company NameN S SURGICAL COMPANY
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Countertrue

Device Dimensions

Length18 Centimeter
Length18 Centimeter
Length18 Centimeter
Length18 Centimeter
Length18 Centimeter
Length18 Centimeter
Length18 Centimeter
Length18 Centimeter
Length18 Centimeter
Length18 Centimeter
Length18 Centimeter
Length18 Centimeter
Length18 Centimeter
Length18 Centimeter
Length18 Centimeter
Length18 Centimeter
Length18 Centimeter
Length18 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCG25008007180 [Primary]

FDA Product Code

HTXRongeur

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[G25008007180]

Ultraviolet Light;Ethylene Oxide;Moist Heat or Steam Sterilization


[G25008007180]

Ultraviolet Light;Ethylene Oxide;Moist Heat or Steam Sterilization


[G25008007180]

Ultraviolet Light;Ethylene Oxide;Moist Heat or Steam Sterilization


[G25008007180]

Ultraviolet Light;Ethylene Oxide;Moist Heat or Steam Sterilization


[G25008007180]

Ultraviolet Light;Ethylene Oxide;Moist Heat or Steam Sterilization


[G25008007180]

Ultraviolet Light;Ethylene Oxide;Moist Heat or Steam Sterilization


[G25008007180]

Ultraviolet Light;Ethylene Oxide;Moist Heat or Steam Sterilization


[G25008007180]

Ultraviolet Light;Ethylene Oxide;Moist Heat or Steam Sterilization


[G25008007180]

Ultraviolet Light;Ethylene Oxide;Moist Heat or Steam Sterilization


[G25008007180]

Ultraviolet Light;Ethylene Oxide;Moist Heat or Steam Sterilization


[G25008007180]

Ultraviolet Light;Ethylene Oxide;Moist Heat or Steam Sterilization


[G25008007180]

Ultraviolet Light;Ethylene Oxide;Moist Heat or Steam Sterilization


[G25008007180]

Ultraviolet Light;Ethylene Oxide;Moist Heat or Steam Sterilization


[G25008007180]

Ultraviolet Light;Ethylene Oxide;Moist Heat or Steam Sterilization


[G25008007180]

Ultraviolet Light;Ethylene Oxide;Moist Heat or Steam Sterilization


[G25008007180]

Ultraviolet Light;Ethylene Oxide;Moist Heat or Steam Sterilization


[G25008007180]

Ultraviolet Light;Ethylene Oxide;Moist Heat or Steam Sterilization


[G25008007180]

Ultraviolet Light;Ethylene Oxide;Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-11
Device Publish Date2023-09-02

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G25008007180 - Spurling Pitutiary Ronguer 4mm/18cm2023-09-11A hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (intervertebral disk) or bone, through a cutting/biting action, during open spinal surgery (e.g., laminectomy, discectomy). It is typically made of metal and designed to withstand the forces required to bite over tough tissue. It is not intended for endoscopic access. This is a reusable device.
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