FDA.reportPublic FDA data

HI-LINE XS

Primary DI
04046963314774
Brand
HI-LINE XS
Company
Aesculap AG
Model
GE645SU
Catalog number
GE645SU
Device description
HI-LINE XS DISP.BARREL BURR III+ D4.0MM
Published
2020-04-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTTBURR, ORTHOPEDIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTTBurr, OrthopedicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046963314774PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046963314774040469633147744046963314774

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
315018218
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046964680878COREHIP EXTENDEDNK1126TNK1126T2020-08-10
04046964681028COREHIP EXTENDEDNK1131TNK1131T2020-08-10
04046964681127COREHIP PRIMARYNK1201KNK1201K2020-08-10
04046964681189COREHIP PRIMARYNK1207KNK1207K2020-08-10
04046964681301COREHIP PRIMARYNK1209KNK1209K2020-08-10
04046964681349COREHIP PRIMARYNK1221KNK1221K2020-08-10
04046964681363COREHIP PRIMARYNK1223KNK1223K2020-08-10
04046964681387COREHIP PRIMARYNK1225KNK1225K2020-08-10
04046964681400COREHIP PRIMARYNK1227KNK1227K2020-08-10
04046964681424COREHIP PRIMARYNK1229KNK1229K2020-08-10
04046964681462COREHIP PRIMARYNK1241KNK1241K2020-08-10
04046964681486COREHIP PRIMARYNK1243KNK1243K2020-08-10
04046964681509COREHIP PRIMARYNK1245KNK1245K2020-08-10
04046964681523COREHIP PRIMARYNK1247KNK1247K2020-08-10
04046964681547COREHIP PRIMARYNK1249KNK1249K2020-08-10
04046963929435NOVOCARTFR719RFR719R2020-08-24
04046963933357NOVOCARTFR651RFR651R2020-08-24
04038653289509NOVOCARTFR661RFR661R2020-08-10
04046963565992NOVOCARTFR660SUFR660SU2020-04-24
04046963939588NOVOCARTFR744RFR744R2020-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899258658230Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-15
07899258658247Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-15
07899258658254Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-15
07899258658261Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-15
07899258658278Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-15
07899258658285Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-15
07899258638867Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-11
07899258638874Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-11
07899258638881Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-11
07899258638898Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-11
07899258638911Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-11
07899258638928Percutaneous Foot Burrs, Arthodesis BurrsGM DOS REIS INDUSTRIA E COMERCIO LTDAHTT2024-01-11
08809288930007IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930014IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930021IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930038IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930045IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930052IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930069IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930076IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930083IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930090IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930106IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930113IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930120IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930137IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930144IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930151IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930168IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13
08809288930175IMEDICOM HIGH SPEED BLADEIMEDICOM CO., LTD.HTT2018-07-13