FDA.reportPublic FDA data

Ace Medical Company

Primary DI
00840217909815
Brand
Ace Medical Company
Company
Ebner Medical, LLC
Model
03-280-101
Catalog number
03-280-101
Device description
"Cloward Style Blade Retr,13mm x 75mm blde,7 1/2"", no lip"
Published
2025-08-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Sterile
true

Product Codes#

Code, Name table
CodeName
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840217909815PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840217909815008402179098158402179098150840217909815

GMDN Terms#

Term, Definition table
TermDefinition
Self-retaining surgical retractor, reusableA hand-operated, self-retaining, one-piece 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 intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a reusable device.

Sterilization Methods#

Method table
Method
High-level Disinfectant

Regulatory Flags#

DUNS number
106135367
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840217910101EBNER MEDICALER300.020BAER300.020BA2025-12-10
00840217910118EBNER MEDICALER305.150EER305.150E2025-12-10
00840217910125Wiggins medical90-403-0190-403-012025-12-10
00840217910132Wiggins medical90-403-022025-12-10
00840217910149Wiggins medical90-403-032025-12-10
00840217910156Wiggins medical90-403-042025-12-10
00840217910163Wiggins medical90-403-052025-12-10
00840217910095Wiggins Medical90-050-18/142B90-050-18/142B2025-11-18
00840217910071Wiggins Medical90-055-52/92B90-055-52/92B2025-10-17
00840217910088Wiggins Medical90-055-52/142B90-055-52/142B2025-10-17
00840217910064Ace Medical CompanyEE1014030EE10140302025-10-14
00840217910033Ace Medical CompanyRBC-TrayRBC-Tray2025-10-08
00840217910040Ace Medical CompanyFETOSCOPIC-TrayFETOSCOPIC-Tray2025-10-08
00840217910057Ace Medical CompanyFCS-TrayFCS-Tray2025-10-08
10840217910009Ace Medical CompanySW001-Box-52025-10-07
20840217910006Ace Medical CompanySW001-Box-102025-10-07
00840217910002Ace Medical CompanySW001-Box12025-10-07
00840217909914Wiggins Medical90-055-18/142B90-055-18/142B2025-09-24
00840217909921Wiggins Medical90-060-36/92B90-060-36/92B2025-09-24
00840217909938Wiggins Medical90-060-36/142B90-060-36/142B2025-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00724995266912Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266943Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
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00724995266974Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266981Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266998Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995267001Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995267025Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995267032Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995267537Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
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