FDA.reportPublic FDA data

NA

Primary DI
H981SD036302200
Brand
NA
Company
Synthes GmbH
Model
SD03.630.220
Catalog number
SD03630220
Device description
STYLET FOR BMA TAPS
Published
2016-12-31
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAHSTYLET, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAHStylet, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034702377PrimaryGS10
H981SD036302200SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503470237710705034702377

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
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
false
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
10705034712307NA03.604.002036040022016-12-31
10705034712802NA03.606.011036060112016-12-31
10705034714592NA03.613.012036130122016-12-31
10705034767819VentroFix304.8343048342016-12-31
10705034768939NA314.0643140642016-12-31
10705034768960Click'X314.0673140672016-12-31
10705034768977Click'X314.0683140682016-12-31
10705034768984Click'X314.0693140692016-12-31
10705034769646NA328.0263280262016-12-31
10705034772608NA388.3643883642016-12-31
10705034775401NA389.2883892882016-12-31
10705034777375NA394.5853945852016-12-31
20705034764051NA292.0202920202019-08-29
00863176000317FIBULINKFGS-1100FGS11002020-03-26
00863176000324FIBULINKFGS-1300FGS13002020-03-26
00863176000300FIBULINKFGS-1000FGS10002017-06-08
10886982113078NA04.130.260S04130260S2016-03-15
10886982077868NA03.311.010033110102015-09-14
10886982077875NA03.311.011033110112015-09-14
10886982077882NA03.311.012033110122015-09-14

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Primary DI, Brand, Company table
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03662663192903Breckenridge ACDF SystemHighridge Medical, LLCGAH2025-12-15
03662663192910Breckenridge ACDF SystemHighridge Medical, LLCGAH2025-12-15
03662663192927Breckenridge ACDF SystemHighridge Medical, LLCGAH2025-12-15
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03662663131520Disc Preparation InstrumentsHighridge Medical, LLCGAH2025-12-03
03662663131537Disc Preparation InstrumentsHighridge Medical, LLCGAH2025-12-03
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08809204330546LIONHans Biomed Corp.GAH2025-11-26
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08809204330577LIONHans Biomed Corp.GAH2025-11-26
08809204330584LIONHans Biomed Corp.GAH2025-11-26
08809204330591LIONHans Biomed Corp.GAH2025-11-26
08809204330607LIONHans Biomed Corp.GAH2025-11-26
08809204330614LIONHans Biomed Corp.GAH2025-11-26
08809204330621LIONHans Biomed Corp.GAH2025-11-26
08809204330638LIONHans Biomed Corp.GAH2025-11-26
08809204330645LIONHans Biomed Corp.GAH2025-11-26
08809204330652LIONHans Biomed Corp.GAH2025-11-26
08809779585853LIONHans Biomed Corp.GAH2025-11-26
08809779585877LIONHans Biomed Corp.GAH2025-11-26
08809204330515LIONHans Biomed Corp.GAH2025-11-18
00873263009062Visualase Neuro AccessoriesFHC, INC.GAH2025-03-10