FDA.report

STRAIGHT STRYKER/ZIMMER HALL ACETABULAR REAMER DRIVER

Primary DI
07630055301413
Brand
STRAIGHT STRYKER/ZIMMER HALL ACETABULAR REAMER DRIVER
Company
Incipio Devices SA
Model
481100140
Catalog number
481100140
Device description
Straight Acetabular Reamer Handle- for hip arthroplasty
Published
2020-07-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07630055301413PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07630055301413076300553014137630055301413

GMDN Terms

TermDefinition
Surgical power tool adaptorA connecting device designed as a mechanical coupling to join and lock together a distal tool to the surgical power tool to provide the power when these are incompatible and are of a different manufacture/industry standard. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of shapes and sizes. This device may be cannulated to allow the use of a guidewire. There are various types such as a Hudson adaptor, Trinkle adaptor, Zimmer adaptor. This is a reusable device.

Sterilization Methods

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 DIBrandModelCatalogPublished
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
07630055306845Offset reamer handle - Stryker Z/H motor shaft131-174/04H502445072026-03-10
07630055306852Offset reamer handle - Hudson motor shaft131-174/04B502445082026-03-10
07630055306869Straight reamer handle - Jacobs - Dual coupling131-171E502445492026-03-10
07630055306876Straight reamer handle - large AO - Dual coupling131-171D502445502026-03-10
07630055306883Straight reamer handle -Stryker Z/H - Dual coupling131-171H502445512026-03-10
07630055306890Straight reamer handle - Hudson - Dual coupling131-171B502445522026-03-10
07630055307057Offset reamer handle - Stryker Z/H - Tri coupling2016REAM502445122026-02-04
07630055300102Offset Cup Impactor - M8x1.25 Interface183-151/00183-151/002019-10-04

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