FDA.reportPublic FDA data

Brasseler

Primary DI
B504OMST60071031100
Brand
Brasseler
Company
Provision
Model
ST6007-103-110
Published
2026-10-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B504OMST60071031100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, single-useA 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 mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device.

Regulatory Flags#

DUNS number
016889401
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B504OMBMAS90006S0BrasselerBMA-S90006S2026-10-20
B504OMBMAS90007S0BrasselerBMA-S90007S2026-10-20
B504OMBMAS90008S0BrasselerBMA-S90008S2026-10-20
B504OMBMLS900040BrasselerBML-S900042026-10-20
B504OMBR2544001110BrasselerBR2544-00-1112026-10-20
B504OMBR9505023020BrasselerBR9505-02-3022026-10-20
B504OMBR9505023030BrasselerBR9505-02-3032026-10-20
B504OMDP86011710BrasselerDP86-0117-12026-10-20
B504OMST60070031000BrasselerST6007-003-1002026-10-20
B504OMST60070031500BrasselerST6007-003-1502026-10-20
B504OMST60071041500BrasselerST6007-104-1502026-10-20
B504OMZB005901020000BrasselerZB00-5901-020-002026-10-20
B504GS80200Vericel80202026-07-20
B504GS80210Vericel80212026-07-20
B504GS80220Vericel80222026-07-20
B504OM19S17050Brasseler19-S17052026-07-20
B504OM22963414S70Stryker2296-3-414S72026-07-20
B504OM3162880Synthes316.2882026-07-20
B504OM4058830Biomet4058832026-07-20
B504OM4058890Biomet4058892026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810141040892Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141040908Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141040915Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141040953Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141040977Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141047532Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141047549Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00840314270351gSourceGSOURCE LLCLXH2026-10-22
00840606175234PrimusSPINAL ELEMENTS, INC.LXH2026-10-22
00840606185820PrimusSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186506LateralSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186513LateralSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186575SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186612SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186643SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186674SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186704SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186735SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186810SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606187091ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-10-22
00840606187121PrimusSPINAL ELEMENTS, INC.LXH2026-10-22
00840606187640OVERWATCHSPINAL ELEMENTS, INC.LXH2026-10-22
00840606189934OVERWATCHSPINAL ELEMENTS, INC.LXH2026-10-22
00840606189941OVERWATCHSPINAL ELEMENTS, INC.LXH2026-10-22
00190776436766MillenniumAvalign Technologies, Inc.LXH2026-10-21
07630699705240Surgical Manual InstrumentMedacta International SALXH2026-10-21
07630699705257Surgical Manual InstrumentMedacta International SALXH2026-10-21
07630699705264Surgical Manual InstrumentMedacta International SALXH2026-10-21
07630699705271Surgical Manual InstrumentMedacta International SALXH2026-10-21
10840642132786Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.LXH2026-10-21