SurgiCount+ 0621-008-108

GUDID 80683534870095

Bulk Lap Sponge, 8"x108", X-Ray Detectable, RFID, STEAM PRETREATMENT, PREWASHED, 200 Pc(s)/Case

A PLUS INTERNATIONAL INC.

Radiopaque woven surgical sponge
Primary Device ID80683534870095
NIH Device Record Key7cf47e9c-81ea-4a5f-86ee-17b984172383
Commercial Distribution StatusIn Commercial Distribution
Brand NameSurgiCount+
Version Model Number1
Catalog Number0621-008-108
Company DUNS191705904
Company NameA PLUS INTERNATIONAL 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100683534870099 [Primary]
GS180683534870095 [Package]
Contains: 00683534870099
Package: Case [200 Units]
In Commercial Distribution

FDA Product Code

NABGauze / Sponge,Nonresorbable For External Use

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[80683534870095]

Moist Heat or Steam Sterilization;Ethylene Oxide


[80683534870095]

Moist Heat or Steam Sterilization;Ethylene Oxide


[80683534870095]

Moist Heat or Steam Sterilization;Ethylene Oxide


[80683534870095]

Moist Heat or Steam Sterilization;Ethylene Oxide


[80683534870095]

Moist Heat or Steam Sterilization;Ethylene Oxide


[80683534870095]

Moist Heat or Steam Sterilization;Ethylene Oxide


[80683534870095]

Moist Heat or Steam Sterilization;Ethylene Oxide


[80683534870095]

Moist Heat or Steam Sterilization;Ethylene Oxide


[80683534870095]

Moist Heat or Steam Sterilization;Ethylene Oxide


[80683534870095]

Moist Heat or Steam Sterilization;Ethylene Oxide


[80683534870095]

Moist Heat or Steam Sterilization;Ethylene Oxide


[80683534870095]

Moist Heat or Steam Sterilization;Ethylene Oxide


[80683534870095]

Moist Heat or Steam Sterilization;Ethylene Oxide


[80683534870095]

Moist Heat or Steam Sterilization;Ethylene Oxide


[80683534870095]

Moist Heat or Steam Sterilization;Ethylene Oxide


[80683534870095]

Moist Heat or Steam Sterilization;Ethylene Oxide


[80683534870095]

Moist Heat or Steam Sterilization;Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-14
Device Publish Date2023-08-04

On-Brand Devices [SurgiCount+]

80683534870125Bulk Vaginal Sponge, 8"X36", 4 ply, STEAM PRETREATMENT, PREWASHED, BLUE LOOP, X-RAY DETECTABLE S
80683534870118Bulk Vaginal Sponge, 4"X36", 4 ply, STEAM PRETREATMENT, PREWASHED, BLUE LOOP, X-RAY DETECTABLE S
80683534870101Bulk Vaginal Sponge, 4"×18", STEAM PRETREATMENT, X-RAY DETECTABLE, RFID, 200 PCS/CS
80683534870095Bulk Lap Sponge, 8"x108", X-Ray Detectable, RFID, STEAM PRETREATMENT, PREWASHED, 200 Pc(s)/Case

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