FDA.reportPublic FDA data

NA

Primary DI
07613327004922
Brand
NA
Company
Stryker GmbH
Model
702805
Catalog number
702805
Device description
Tap AO Fitting
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWCScrew, fixation, bone
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327004922PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327004922076133270049227613327004922

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA metal surgical instrument designed for cutting internal threads into bone so that the threads facilitate the insertion of bone screws. The screws anchor bone fragments, fixtures and/or other devices to the bone. It is made of high-grade stainless steel and has a helical thread intersected with longitudinal cutting grooves forming the cutting edges at its distal end and may be cannulated. The proximal end typically terminates in a square to which a tapping instrument or extension can be attached. It will typically be manually rotated in order to create a best possible thread. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length180Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
481999654
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327625066PANGEA5421165421162024-12-01
00886385019741SR PIP17-13152017-06-27
00886385019758SR PIP17-13162017-06-27
00886385019765SR PIP17-13172017-06-27
00886385019772SR PIP17-13182017-06-27
00886385019789SR PIP17-13192017-06-27
00886385019796SR PIP17-13202017-06-27
00886385019802SR PIP17-13212017-06-27
00886385019819SR PIP17-13222017-06-27
00886385019826SR PIP17-13232017-06-27
00886385019833SR PIP17-13242017-06-27
00886385019840SR PIP17-13252017-06-27
00886385019857SR PIP17-13262017-06-27
00886385019864SR PIP17-13272017-06-27
00886385019871SR PIP17-13282017-06-27
00886385019888SR PIP17-13292017-06-27
00886385019895SR PIP17-13302017-06-27
00886385019901SR PIP17-13312017-06-27
00886385019918SR PIP17-13322017-06-27
00886385019925SR PIP17-13332017-06-27

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Primary DI, Brand, Company table
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