FDA.reportPublic FDA data

Wedge 4, Round shank

Primary DI
24053613290955
Brand
Wedge 4, Round shank
Company
Gebr. Brasseler GmbH & Co. KG
Model
AR-301-B101
Catalog number
AR-301-B101
Published
2025-07-18
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
GFFBur, Surgical, General & Plastic Surgery

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24053613290955PackageGS11In Commercial Distribution
14053613290958PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2405361329095524053613290955
1405361329095814053613290958

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bur, single-useA sterile, rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate/shape bone tissue during small and large bone surgery (e.g., maxillofacial, spinal, or orthopaedic). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
317409001
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
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
14053613286357Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.425S05.005.425S2026-09-25
14053613286388Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.464S05.005.464S2026-09-25
14053613286401Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.434S05.005.434S2026-09-25
14053613286463Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.466S05.005.466S2026-09-25
14053613286500Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.435S05.005.435S2026-09-25
14053613286623Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.005.105S05.005.105S2026-09-25
14053613286807Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.170S05.519.170S2026-09-25
14053613286838Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.230S05.519.230S2026-09-25
14053613286845Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.104S05.519.104S2026-09-25
14053613286852Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.103S05.519.103S2026-09-25
14053613286869Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.250S05.519.250S2026-09-25
14053613286876Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.105S05.519.105S2026-09-25
14053613286883Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.150S05.519.150S2026-09-25
14053613286890Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.100S05.519.100S2026-09-25
14053613286913Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.301S05.519.301S2026-09-25
14053613286920Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.302S05.519.302S2026-09-25
14053613286937Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II05.519.303S05.519.303S2026-09-25
14053613293133KOMET Surgical BurSC2834.502..K1SC2834.502.2026-09-25
14053613295649Reciprocating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II, UNIUM05.005.906S05.005.906S2026-09-25
14053613295694Reciprocating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II, UNIUM05.005.914S05.005.914S2026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14053613293133KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2026-09-25
05051471225985De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2026-08-01
00817438028724N/AOmega Surgical Instruments IncGFF2026-07-24
00817438028755N/AOmega Surgical Instruments IncGFF2026-07-21
10080196377244MEDLINEMEDLINE INDUSTRIES, INC.GFF2025-01-29
10080196385560MEDLINEMEDLINE INDUSTRIES, INC.GFF2025-01-29
10845854012581VORTEX, STERLINGConmed CorporationGFF2023-01-19
10845854012598VORTEX, STERLINGConmed CorporationGFF2023-01-19
10845854017791STERLINGConmed CorporationGFF2023-01-19
10845854029626STERLINGConmed CorporationGFF2023-01-19
10845854029671LIGHTNING, STERLINGConmed CorporationGFF2023-01-19
10845854040621ULTRATIGERConmed CorporationGFF2023-01-19
10080196377299MedlineMEDLINE INDUSTRIES, INC.GFF2022-05-12
10080196385577MedlineMEDLINE INDUSTRIES, INC.GFF2022-05-12
10884389198537MedlineMEDLINE INDUSTRIES, INC.GFF2022-05-12
10653160274797CenturionCENTURION MEDICAL PRODUCTS CORPORATIONGFF2022-01-01
10653160276982CenturionCENTURION MEDICAL PRODUCTS CORPORATIONGFF2022-01-01
10653160281672CenturionCENTURION MEDICAL PRODUCTS CORPORATIONGFF2022-01-01
10653160282402CenturionCENTURION MEDICAL PRODUCTS CORPORATIONGFF2022-01-01
10653160290797CenturionCENTURION MEDICAL PRODUCTS CORPORATIONGFF2022-01-01
10653160321668CenturionCENTURION MEDICAL PRODUCTS CORPORATIONGFF2022-01-01
10845854018125STERLINGConmed CorporationGFF2021-10-15
10845854017210STERLINGConmed CorporationGFF2021-10-14
10845854029596CONMEDConmed CorporationGFF2021-10-14
10845854029602CONMEDConmed CorporationGFF2021-10-14
10845854029619STERLING SOUTHPAWConmed CorporationGFF2021-10-14
10845854017432STERLINGConmed CorporationGFF2021-10-13
10845854017593STERLINGConmed CorporationGFF2021-10-13
10845854036563STERLING SOUTHPAWConmed CorporationGFF2021-10-13
10845854000687CONMEDConmed CorporationGFF2020-09-24