ACS

GUDID 00191072117472

ENT - THYROID PACK 147296

AMERICAN CONTRACT SYSTEMS, INC.

General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use
Primary Device ID00191072117472
NIH Device Record Key376109de-6672-4000-b32c-a85502e615f2
Commercial Distribution StatusIn Commercial Distribution
Brand NameACS
Version Model NumberJRET18H
Company DUNS010334675
Company NameAMERICAN CONTRACT SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100191072117472 [Primary]
GS100191072117472 [Primary]
GS100191072117472 [Primary]
GS100191072117472 [Primary]
GS100191072117472 [Primary]
GS100191072117472 [Primary]
GS100191072117472 [Primary]
GS100191072117472 [Primary]
GS100191072117472 [Primary]
GS100191072117472 [Primary]
GS100191072117472 [Primary]
GS100191072117472 [Primary]
GS100191072117472 [Primary]
GS100191072117472 [Primary]
GS100191072117472 [Primary]

FDA Product Code

OGREar, nose, and throat surgical tray
OGREar, nose, and throat surgical tray
OGREar, nose, and throat surgical tray
OGREar, nose, and throat surgical tray
OGREar, nose, and throat surgical tray
OGREar, nose, and throat surgical tray
OGREar, nose, and throat surgical tray
OGREar, nose, and throat surgical tray
OGREar, nose, and throat surgical tray
OGREar, nose, and throat surgical tray
OGREar, nose, and throat surgical tray
OGREar, nose, and throat surgical tray
OGREar, nose, and throat surgical tray
OGREar, nose, and throat surgical tray
OGREar, nose, and throat surgical tray

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00191072117472]

Ethylene Oxide


[00191072117472]

Ethylene Oxide


[00191072117472]

Ethylene Oxide


[00191072117472]

Ethylene Oxide


[00191072117472]

Ethylene Oxide


[00191072117472]

Ethylene Oxide


[00191072117472]

Ethylene Oxide


[00191072117472]

Ethylene Oxide


[00191072117472]

Ethylene Oxide


[00191072117472]

Ethylene Oxide


[00191072117472]

Ethylene Oxide


[00191072117472]

Ethylene Oxide


[00191072117472]

Ethylene Oxide


[00191072117472]

Ethylene Oxide


[00191072117472]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-16
Device Publish Date2020-10-08

On-Brand Devices [ACS]

00191072000057OUTPATIENT PORT ACCESS KIT
00191072000040LABOR DELIVERY PACK - 213387
00191072000033C-SECTION PACK 2 - 242901
00191072000026C-SECTION PACK - 205965
00191072000019CLEAN CLOSURE PACK - 289126
00191072000002STANDARD ARTHROSCOPY PACK - 291852
00191072000071LEVEL 1 PPE KIT (REV 3)NONSTERILE-277567
00191072000064LEVEL 2A PPE KIT(REV 4)NONSTERILE-288133
00191072033383T&A PACK
00191072032652PROMEDICA BARRIER KIT
00191072032478CNRV PERIPHERAL VAS
00191072032447CNRV MAJ LITH/LAVH ACC
00191072032416CNRV LITHOTOMY
00191072032348CNRV GYN LAP
00191072032324CNRV CAROTID ACCESS
00191072031983GU-GYN-LITHO PACK
00191072031921CV PACK
00191072031419PEDS HEART DONOR PACK
00191072031075ADULT HEART DONOR PACK
00191072030986ER PELVIC KIT
00191072030948D & C PACK
00191072030634KNEE ARTHROSCOPY
00191072030573TOTAL KNEE
00191072030566SHOULDER PACK
00191072030535LAP CHOLE PACK
00191072030221BARRIER PACK
00191072030153OPEN HEART A PACK
00191072030054CDC COMPLIANCE KIT
00191072029560CMC POSTERIOR HIP PACK
00191072029546VALVE REPLACEMENT
00191072029348CMC TOTAL KNEE
00191072029324ANTERIOR HIP PACK
00191072029287CMC LABOR AND DELIVERY
00191072029126CORONARY BYPASS
00191072029072BREAST PROCEDURE
00191072028075BIOPSY TRAY
00191072027672T & A PACK VARNER PACL
00191072027658RADIOLOGY DRAPE PACK
00191072027597MAJOR LITHOTOMY PACK
00191072027573KYPHOPLASTY PACK
00191072026927ACDF
00191072025586HEART CABG
00191072024800TONSILS AND ADNOIDS
00191072024251VASCULAR PACK
00191072024206PAIN PACK
00191072024190OB GYN LAPAROSCOPIC TRAY
00191072024169HYSTEROSCOPY PACK
00191072024039RADIOLOGY ARTERIOGRAM PACK
00191072023964LAVH
00191072023933CUSTOM HEART PACK II

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