Inge Spreader (Child) 16cm 09-069-16

GUDID G25009069160

A hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.

N S SURGICAL COMPANY

Hand-held surgical retractor, reusable
Primary Device IDG25009069160
NIH Device Record Key635f036c-c186-48c7-ab68-70ad2cd2c1f2
Commercial Distribution StatusIn Commercial Distribution
Brand NameInge Spreader (Child) 16cm
Version Model Number09-069-16
Catalog Number09-069-16
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

Length16 Centimeter
Length16 Centimeter
Length16 Centimeter
Length16 Centimeter
Length16 Centimeter
Length16 Centimeter
Length16 Centimeter
Length16 Centimeter
Length16 Centimeter
Length16 Centimeter
Length16 Centimeter
Length16 Centimeter
Length16 Centimeter
Length16 Centimeter
Length16 Centimeter
Length16 Centimeter
Length16 Centimeter
Length16 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCG25009069160 [Primary]

FDA Product Code

GADRetractor

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[G25009069160]

Ethylene Oxide;Ultraviolet Light;Moist Heat or Steam Sterilization


[G25009069160]

Ethylene Oxide;Ultraviolet Light;Moist Heat or Steam Sterilization


[G25009069160]

Ethylene Oxide;Ultraviolet Light;Moist Heat or Steam Sterilization


[G25009069160]

Ethylene Oxide;Ultraviolet Light;Moist Heat or Steam Sterilization


[G25009069160]

Ethylene Oxide;Ultraviolet Light;Moist Heat or Steam Sterilization


[G25009069160]

Ethylene Oxide;Ultraviolet Light;Moist Heat or Steam Sterilization


[G25009069160]

Ethylene Oxide;Ultraviolet Light;Moist Heat or Steam Sterilization


[G25009069160]

Ethylene Oxide;Ultraviolet Light;Moist Heat or Steam Sterilization


[G25009069160]

Ethylene Oxide;Ultraviolet Light;Moist Heat or Steam Sterilization


[G25009069160]

Ethylene Oxide;Ultraviolet Light;Moist Heat or Steam Sterilization


[G25009069160]

Ethylene Oxide;Ultraviolet Light;Moist Heat or Steam Sterilization


[G25009069160]

Ethylene Oxide;Ultraviolet Light;Moist Heat or Steam Sterilization


[G25009069160]

Ethylene Oxide;Ultraviolet Light;Moist Heat or Steam Sterilization


[G25009069160]

Ethylene Oxide;Ultraviolet Light;Moist Heat or Steam Sterilization


[G25009069160]

Ethylene Oxide;Ultraviolet Light;Moist Heat or Steam Sterilization


[G25009069160]

Ethylene Oxide;Ultraviolet Light;Moist Heat or Steam Sterilization


[G25009069160]

Ethylene Oxide;Ultraviolet Light;Moist Heat or Steam Sterilization


[G25009069160]

Ethylene Oxide;Ultraviolet Light;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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