FDA.reportPublic FDA data

Stryker Varispeed

Primary DI
07613252732051
Brand
Stryker Varispeed
Company
Stryker Leibinger GmbH & Co. KG
Model
62-50201
Catalog number
62-50201
Device description
Battery pack for VariSpeed
Published
2016-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEYMOTOR, SURGICAL INSTRUMENT, AC-POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEYMotor, Surgical Instrument, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613252732051PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613252732051076132527320517613252732051

GMDN Terms#

Term, Definition table
TermDefinition
Surgical power tool system handpiece, rotary, non-rechargeable battery-powered, reusableA hand-held device intended to provide rotation for a rotary endpiece instrument during surgical procedures performed on bones and tough tissues (e.g., cartilage, ligaments). It typically has the capacity to be used with a variety of rotary instruments (e.g., drill bits, reamers) and is not dedicated to a specific clinical procedure. It includes a built-in motor and an attachment for direct connection of an endpiece(s) [which is not included]. It is powered by a single-use sterile battery pack that normally will attach to, or is inserted into, the handpiece. The device may be cannulated to allow the use of a guidewire, and may be of the micro or macro design. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
316153956
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613252578208NA78-2102878-210282015-07-03
07613252578215NA78-2002878-200282015-07-03
07613252578222NA78-2002078-200202015-07-03
07613252578239NA78-2102078-210202015-07-03
07613252599647NA78-3002078-300202015-07-03
07613252599654NA78-3002878-300282015-07-03
07613252599661NA78-3102078-310202015-07-03
07613252599678NA78-3102878-310282015-07-03
07613327392715DELTA70-7620170-762012018-06-07
04546540364883NA50-1290050-129002023-02-13
07613327369489AXS62-1217862-121782019-09-11
04546540246332NA60-1010460-101042016-08-24
04546540246356NA60-1010860-101082016-08-24
04546540246387NA60-1011260-101122016-08-24
04546540256805NA62-0053462-005342016-10-19
04546540258991NA62-1740162-174012016-10-19
04546540274175NA64-0010564-001052016-12-08
04546540274250NA64-0013264-001322017-01-11
04546540356758NA64-0024264-002422016-12-08
04546540356765NA64-0024364-002432016-12-08

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