FDA.reportPublic FDA data

Ace Medical Company

Primary DI
00840217910293
Brand
Ace Medical Company
Company
EBNER MEDICAL, LLC
Model
ER806.000PA
Catalog number
ER806.000PA
Device description
Cassette made of aluminum, PTFE for 3-in-One premium systems
Published
2026-08-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840217910293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840217910293008402179102938402179102930840217910293

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
800-822-0314info@acemedicalco.com

Regulatory Flags#

DUNS number
106135367
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840217910002Ace Medical CompanySW001-Box12025-10-07
00840217908351Wiggins MedicalWM-SCTRAY001WM-SCTRAY-0012023-08-23
00840217907057ACE MedicalAA9791823AA97918232022-08-25
00840217910170Ace Medical CompanyAA4021010AA40210102026-08-13
00840217910187Ace Medical CompanyAA4021015AA40210152026-08-13
00840217910194Ace Medical CompanyAA4021023AA40210232026-08-13
00840217910200Ace Medical CompanyAA4021223AA40212232026-08-13
00840217910217Ace Medical CompanyAA4021215AA40212152026-08-13
00840217910224Ace Medical CompanyAA4021410AA40214102026-08-13
00840217910231Ace Medical CompanyAA4021415AA40214152026-08-13
00840217910248Ace Medical CompanyAA40214232026-08-13
00840217910255Ace Medical CompanyAA4021605AA40216052026-08-13
00840217910262Ace Medical CompanyAA4021608AA40216082026-08-13
00840217910279Ace Medical CompanyECA-A008ECA-A0082026-08-13
00840217910286Wiggins Medical90-070-25FB90-070-25FB2026-08-13
00840217910309Ace Medical CompanyER806.000VAER806.000VA2026-08-13
00840217910316Ace Medical CompanyER300.010ERER300.010ER2026-08-13
00840217910323Ace Medical CompanyER305.200ER1ER305.200ER12026-08-13
00840217910330Ace Medical CompanyER305.150EER305.150E2026-08-13
00840217910347Ace Medical CompanyER300.020BAER300.020BA2026-08-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385640095488INSTRUSAFESummit Medical, Inc.KCT2026-11-05
00385640095471INSTRUSAFESummit Medical, Inc.KCT2026-11-04
10886982278746NASynthes GmbHKCT2026-11-03
10886982346421NASynthes GmbHKCT2026-11-03
00385640095433INSTRUSAFESummit Medical, Inc.KCT2026-11-02
00841536147971ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
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00841536148367ThompsonThompson Surgical Instruments, Inc.KCT2026-09-08
00841536147445ThompsonThompson Surgical Instruments, Inc.KCT2026-08-26
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00841536147322ThompsonThompson Surgical Instruments, Inc.KCT2026-08-25
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00841536148459ThompsonThompson Surgical Instruments, Inc.KCT2026-08-06
00841536148466ThompsonThompson Surgical Instruments, Inc.KCT2026-08-06
00841536147162ThompsonThompson Surgical Instruments, Inc.KCT2025-12-09
00841536146516ThompsonThompson Surgical Instruments, Inc.KCT2025-09-10
00841536146523ThompsonThompson Surgical Instruments, Inc.KCT2025-09-10
00841536146875ThompsonThompson Surgical Instruments, Inc.KCT2025-08-28
00841536146912ThompsonThompson Surgical Instruments, Inc.KCT2025-07-08