FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653004751
Brand
AESCULAP
Company
Aesculap AG
Model
GD049R
Catalog number
GD049R
Device description
ROSEN BURR D3.1MM/ISO 031 2.35X70MM
Published
2020-04-17
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
HTTBURR, ORTHOPEDIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTTBurr, OrthopedicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653004751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653004751040386530047514038653004751

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
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
315018218
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
04038653033997AESCULAPDC230RDC230R2020-06-17
04038653034321AESCULAPDE112RDE112R2020-06-17
04038653034369AESCULAPDE116RDE116R2020-06-17
04038653034376AESCULAPDE117RDE117R2020-06-17
04038653034406AESCULAPDE120RDE120R2020-06-17
04038653034901AESCULAPDE676RDE676R2020-06-17
04046963116194S4 CERVICALFW028UFW028U2020-08-24
04046963794248ELAN 4GA768GA7682020-04-24
04046963935184HI-LINE XXSGE813SUGE813SU2020-04-24
04046963935191HI-LINE XXSGE814SUGE814SU2020-04-24
04046963966362ELAN 4GA767GA7672020-04-24
04046964054907ELAN 4GA715RGA715R2020-04-24
04046964076664AESCULAPGE812SUGE812SU2020-04-24
04046964526213ECCOSGB068RGB068R2020-04-24
04038653177035AESCULAPOG963ROG963R2016-09-23
04038653242962AESCULAPDF262RDF262R2020-06-17
04038653339563AESCULAPJG901JG9012025-03-22
04038653345038AESCULAPJG910JG9102020-05-20
04038653038244AESCULAPDP511RDP511R2020-06-17
04038653038251AESCULAPDP512RDP512R2020-06-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B390030001131Reprocessed 2.3mm Lindemann ReamerSURETEK MEDICALHTT2025-07-18
08057717551020SHANNON STD BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551082SHANNON ISHAM BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551143CONICAL BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551204CONICAL BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551266CYLINDRICAL STRAIGHT BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551327CYLINDRICAL STRAIGHT BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551389CYLINDRICAL STRAIGHT BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551457WEDGE BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551525WEDGE BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551587ROUNDED BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551648ROUNDED BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551709BROPHY BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717550962SHANNON SHORT BURRBRM EXTREMITIES SRLHTT2025-03-27
B504OM0228013S0BrasselerProvisionHTT2025-02-05
B504OM030000170SynthesProvisionHTT2025-02-05
B504OM030000700SynthesProvisionHTT2025-02-05
B504OM03228015S0BrasselerProvisionHTT2025-02-05
B504OM03228017S0BrasselerProvisionHTT2025-02-05
B504OM04C03060BrasselerProvisionHTT2024-08-08
B504OM5300107140StrykerProvisionHTT2024-08-08
B504OM5300309010StrykerProvisionHTT2024-08-08
B504OM58200800210StrykerProvisionHTT2024-08-08
00840124512801FuzeFix Chamfered ScrewsFUSION ORTHOPEDICS, LLCHTT2024-06-27
B504OMAR300B1010ArthrexProvisionHTT2024-06-10
B504OM5300105070StrykerProvisionHTT2024-05-28
B504OM13750520ConMedProvisionHTT2024-05-22
B504OM13750530ConMedProvisionHTT2024-05-22
B504OMDW311055R0VilexProvisionHTT2024-05-22
B504OM50911020ConMedProvisionHTT2024-05-16