ACS

GUDID 00191072090065

SFCH MINOR GENERAL SURGERY (PS 122093)

AMERICAN CONTRACT SYSTEMS, INC.

General/plastic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 00191072090065
• NIH Device Record Key: 31ddefe8-1478-44d0-b161-61f4b9e07e0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACS
• Version Model Number: UIGN80F
• Company DUNS: 010334675
• Company Name: AMERICAN CONTRACT SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191072090065 [Primary]

FDA Product Code

• LRO: General surgery tray

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00191072090065]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-27
• Device Publish Date: 2019-11-19

On-Brand Devices [ACS]

• 00191072054692: EAR PACK
• 00191072054265: TOTAL HIP
• 00191072054258: KNEE PACK
• 00191072054241: ADULT BLOOD CULTURE KIT NON STERILE
• 00191072054234: VEIN HARVESTING PACK-LF
• 00191072054227: ASC TOTAL KNEE PACK
• 00191072054210: CYSTO PACK - 226806
• 00191072054203: HYSTEROSCOPY PACK - 251841
• 00191072054197: ELECTROPHYSIOLOGY PACK - 205998
• 00191072054180: STRADLE TABLE PACK - 301659
• 00191072054173: HIP SCOPE 500302
• 00191072054166: TOTAL JOINT PACK
• 00191072054159: PLASTIC PACK
• 00191072054142: LAMINECTOMY
• 00191072054135: ARTHROSCOPY PACK
• 00191072054128: ORIF HIP - IM RODDING FEMUR
• 00191072054111: ENT PACK
• 00191072054104: CYSTO-TUR PACK-LF
• 00191072054098: ACDF
• 00191072054081: KNEE ARTHROSCOPY PACK
• 00191072054074: CYSTO PACK
• 00191072054067: FLOWER GYN PACK
• 00191072054050: TOTAL KNEE
• 00191072054043: SHOULDER PACK
• 00191072054036: EXTREMITY DRAPE
• 00191072054029: ARTHROSCOPY PACK
• 00191072054012: GYN-GU
• 00191072054005: HYSTEROSCOPY PACK
• 00191072053992: PACEMAKER DEVICE PACK
• 00191072053985: DA VINCI PACK 35699
• 00191072053978: PACER/ICD PACK / 28073
• 00191072053961: CAB PACK/25181
• 00191072053954: CV PACK (ST JOES) / 4801
• 00191072053947: C-SECTION PACK
• 00191072053930: BASIC PACK
• 00191072053923: PAIN PACK
• 00191072053916: MAJOR ORTHO PACK
• 00191072053909: CATH LAB ANGIO
• 00191072053893: TRAUMA PACK 500212
• 00191072053886: TRAUMA BASIN SET 500212
• 00191072053879: FISTULOGRAM PACK
• 00191072053862: TRAUMA COMBO PACK 500212
• 00191072053855: INTERVENTIONAL RADIOLOGY PACK
• 00191072053848: PACEMAKER PACK
• 00191072053831: SINUS PACK
• 00191072053824: MINOR ORTHO PACK
• 00191072053817: LAPAROTOMY PACK
• 00191072053800: D&C PACK
• 00191072053794: SOFT TISSUE PACK
• 00191072053787: TONSIL PACK