FDA.reportPublic FDA data

ACE Acetabular Reamer Tray - Instrument Tray

Primary DI
07630055307736
Brand
ACE Acetabular Reamer Tray - Instrument Tray
Company
Incipio Devices SA
Model
50740101
Catalog number
50740105
Device description
Surgical instrument tray for Incipio Devices instrumentation
Published
2026-04-30
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

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630055307736PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630055307736076300553077367630055307736

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
485098284
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
07630055307781Positioning handle - M8x1 interface75.70.05775.70.0572026-07-16
07630055307798Positioning handle - M10x1.5 interface75.70.05975.70.0592026-07-16
07630055307804Offset Cup Impactor - M8x1 interface01.15.10.055601.15.10.05562026-07-16
07630055307811Offset Cup Impactor - M10x1.5 interface01.15.10.055501.15.10.05552026-07-16
07630055302458Offset Cup Impactor - M8x1 interface01.15.10.055601.15.10.05562020-04-23
07630055302465Offset Cup Impactor - M10x1.5 interface01.15.10.055501.15.10.05552020-04-23
07630055307026Offset Reamer Handle - Large AO - Tri coupling922061T502445112026-05-07
07630055307033Offset reamer handle - Tri Coupling Transmission922061T-EZ502445102026-05-07
07630055306722Offset reamer handle - Dual Coupling90CH.IN.004502445002026-03-17
07630055306739Offset reamer handle - Large AO motor shaft90CH.IN.AO1502445062026-03-17
07630055306746Offset reamer handle - Stryker Z/H motor shaft90CH.IN.ZH1502445072026-03-17
07630055306753Offset reamer handle - Hudson motor shaft90CH.IN.HU1502445082026-03-17
07630055306760Straight reamer handle - large AO - Dual coupling90ST.IN.AO1502445502026-03-17
07630055306777Straight reamer handle -Stryker Z/H - Dual coupling90ST.IN.ZH1502445512026-03-17
07630055306784Straight reamer handle - Hudson - Dual coupling90ST.IN.HU1502445522026-03-17
07630055306791Offset reamer handle - Dual coupling131-174/05502445002026-03-10
07630055306807Offset reamer handle - Handle131-174/01502445042026-03-10
07630055306814Offset reamer handle - Body131-174/02502445052026-03-10
07630055306821Offset reamer handle - Dual Coupling transmission131-174/03502445092026-03-10
07630055306838Offset reamer handle - Large AO motor shaft131-174/04D502445062026-03-10

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