FDA.reportPublic FDA data

NA

Primary DI
07611819865853
Brand
NA
Company
Synthes GmbH
Model
03.025.104
Catalog number
03025104
Device description
2.9/3.2MM THREE-FLT DRL BIT QC 331MM/100MM CALIB FOR 4.0 ASL
Published
2022-07-14
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

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819865853Direct MarkingGS10
10886982070074PrimaryGS10
H679030251040SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819865853076118198658537611819865853
1088698207007410886982070074

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, reusableA 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
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
10886982350435NASD03.100.130SD031001302026-02-11
10886982350442NASD03.100.131SD031001312026-02-11
10886982350459NASD03.100.132SD031001322026-02-11
10886982350466NASD03.100.133SD031001332026-02-11
10886982351579NASD399.190SD3991902026-02-11
10886982351661NASD03.010.001SD030100012026-02-11
10886982351678NASD03.010.002SD030100022026-02-11
10886982361288NASD03.405.001SD034050012026-02-11
10886982361295NASD03.100.038SD031000382026-02-11
10887587078502NASD03.501.443SD035014432026-02-11
10887587078571NASD386.902SD3869022026-02-11
10886982351586NASD03.045.001SD030450012026-02-10
10886982351593NASD03.045.003SD030450032026-02-10
10886982362186NASD03.233.016SD032330162026-01-10
10886982362193NASD03.233.017SD032330172026-01-10
10886982362209NASD03.233.018SD032330182026-01-10
10886982362216NASD03.233.019SD032330192026-01-10
10886982361257VOLT60.529.210605292102025-12-16
H9810460002902S0NA04.600.029.02S0460002902S2019-08-20
H9810460002910S0NA04.600.029.10S0460002910S2019-08-20

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810111227148K-WireTreace Medical Concepts, Inc.HWE2026-03-23
10885862661555N/AExactech, Inc.HWE2026-03-19
00888867529762Arthrex®ARTHREX, INC.HWE2026-03-16
00888867529779Arthrex®ARTHREX, INC.HWE2026-03-16
00888867529809Arthrex®ARTHREX, INC.HWE2026-03-16
00888867529830Arthrex®ARTHREX, INC.HWE2026-03-16
00888867529847Arthrex®ARTHREX, INC.HWE2026-03-16
00888867531628Arthrex®ARTHREX, INC.HWE2026-03-16
00888867531635Arthrex®ARTHREX, INC.HWE2026-03-16
00888867531680Arthrex®ARTHREX, INC.HWE2026-03-16
00888867531727Arthrex®ARTHREX, INC.HWE2026-03-16
09421038412145Cup reamer handle, offset, Z/H, lockingENZTEC LIMITEDHWE2026-03-09
09421038412152Offset coupling, Z/HENZTEC LIMITEDHWE2026-03-09
09421038412169Offset drive train, lockingENZTEC LIMITEDHWE2026-03-09
09421038412176Short Offset Cover – UnitedENZTEC LIMITEDHWE2026-03-09
09421038412183Handle – UnitedENZTEC LIMITEDHWE2026-03-09
09421038412299Cup reamer handle, offset, AO, lockingENZTEC LIMITEDHWE2026-03-09
09421038412305Offset coupling, AOENZTEC LIMITEDHWE2026-03-09
09421038412312Cup reamer handle, offset, AO, openENZTEC LIMITEDHWE2026-03-09
09421038412329Offset drive train, openENZTEC LIMITEDHWE2026-03-09
09421038412671Cup reamer handle, offset, Z/H, openENZTEC LIMITEDHWE2026-03-09
00810111225601ReamerTreace Medical Concepts, Inc.HWE2026-03-02
00810111225618ReamerTreace Medical Concepts, Inc.HWE2026-03-02
00810111225625ReamerTreace Medical Concepts, Inc.HWE2026-03-02
09421038411865Enztec Modular OCI XENZTEC LIMITEDHWE2026-02-27
09421038412138Enztec Modular OCI XRENZTEC LIMITEDHWE2026-02-27
00888867536746Arthrex®ARTHREX, INC.HWE2026-02-25
00888867536760Arthrex®ARTHREX, INC.HWE2026-02-25
00888867536777Arthrex®ARTHREX, INC.HWE2026-02-25
09421038412725Enztec Reamer 36mm - BridgebackENZTEC LIMITEDHWE2026-02-23