FDA.reportPublic FDA data

NA

Primary DI
10886982070128
Brand
NA
Company
Synthes GmbH
Model
03.025.126
Catalog number
03025126
Device description
4.9/5.0MM 3-FLT DRL BIT 145MM F/6.0MM ASLS F/RADIOLUCENT DRV
Published
2022-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTWBIT, DRILL
HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819865938Direct MarkingGS10
10886982070128PrimaryGS10
H679030251260SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819865938076118198659387611819865938
1088698207012810886982070128

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, reusable"A shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a ""twist drill"", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982030054LCP02.108.412021084122015-09-14
10886982033079VA-LCP02.112.049021120492015-09-14
10886982042590LCP02.124.213021242132015-09-14
10886982055552NA02.221.002S02221002S2015-09-14
10886982055569NA02.221.003S02221003S2015-09-14
10886982055583NA02.221.004S02221004S2015-09-14
10886982076748NA03.221.015032210152016-12-31
10886982076762NA03.221.016032210162016-12-31
10886982076779NA03.221.017032210172016-12-31
10886982120960NA04.221.002S04221002S2015-09-14
10886982120977NA04.221.003S04221003S2015-09-14
10886982120991NA04.221.004S04221004S2015-09-14
10886982182494NA298.800.01S29880001S2015-09-14
10886982182500NA298.801.01S29880101S2015-09-14
10886982198112NA391.1033911032016-12-31
10886982198129NA391.1043911042016-12-31
10886982198136NA391.1053911052016-12-31
10886982198143NA391.1063911062016-12-31
10886982198150NA391.1073911072016-12-31
10886982198167NA391.1083911082016-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00842078130261CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078130315CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078130452CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078130490CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078130537CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134054CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134061CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134078CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134085CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134092CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134108CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134115CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
04052536176700neon3Ulrich GmbH & Co. KGHTW2026-06-08
04052536176717neon3Ulrich GmbH & Co. KGHTW2026-06-08
00850078396303PFT Adapter, SYK, Virata, 85 in-lb (228-TXRX-006)Eca Medical InstrumentsHWE2026-06-05
00850078396310PFT Adapter, SYK, Mariner, 105 in-lb (228-TXRX-007)Eca Medical InstrumentsHWE2026-06-05
00196449017355A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017362A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017409A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017416A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017423A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017430A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017447A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017461A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017478A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017485A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017492A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017508A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04