FDA.reportPublic FDA data

HI-LINE

Primary DI
04038653300587
Brand
HI-LINE
Company
Aesculap AG
Model
GD711R
Catalog number
GD711R
Device description
HI-LINE DIAMOND BURR II EXCEPT.LG.D4.5MM
Published
2020-04-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEFAPPLIER, STAPLE, SURGICAL,

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEFApplier, Staple, Surgical,General, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653300587PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653300587040386533005874038653300587

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bur, reusableA 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 reusable 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
DM exempt
true
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
04038653300532HI-LINEAesculap AGGEF2020-04-23
04038653300570HI-LINEAesculap AGGEF2020-04-23
00192896090675MICHEL CLIP APPLIER/REMOVER FORCEPSSONTEC INSTRUMENTS, INC.GEF2019-03-07
10886705013142INTRAFIXDEPUY MITEK, LLCGEF2017-03-17
00889024024540NAZimmer, Inc.GEF2016-07-27
10886705009930NADEPUY MITEK, LLCGEF2015-09-01
10886705010059NADEPUY MITEK, LLCGEF2015-09-01
10886705001910GIIDEPUY MITEK, LLCGEF2015-09-01
10886705001927NADEPUY MITEK, LLCGEF2015-09-01
10886705001934NADEPUY MITEK, LLCGEF2015-09-01
10886705002986RIGIDFIXMedos International SàrlGEF2015-09-01
10886705003761GIIDEPUY MITEK, LLCGEF2015-09-01
10886705006809TACITDEPUY MITEK, LLCGEF2015-09-01