FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653176915
Brand
AESCULAP
Company
Aesculap AG
Model
OG202R
Catalog number
OG202R
Device description
HEERMANN CHISEL X-SM 0.7MM
Published
2020-04-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JYECHISEL, MIDDLE-EAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYEChisel, Middle-EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653176915PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653176915040386531769154038653176915

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic chiselA hand-held, single-blade surgical instrument, bevelled on one side, designed to cut and shape bone during orthopaedic surgery. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, flat or curved [(concave) - also known as a hollow blade] in design. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). 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
true
Premarket exempt
true
Lot or batch
true
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
04038653013845AESCULAPOP297ROP297R2017-07-31
04038653081141AESCULAPOP913OP9132016-09-23
04038653081158AESCULAPOP914OP9142020-08-10
04038653013852AESCULAPOP298ROP298R2020-04-17
04046963730109AESCULAPOP923OP9232019-04-30
04046955273508AICONJJ612JJ6122022-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770405220Bausch + LombBausch & Lomb IncorporatedJYE2025-08-08
00757770409693Bausch + LombBausch & Lomb IncorporatedJYE2025-08-08
00757770413140Bausch + LombBausch & Lomb IncorporatedJYE2025-08-08
00757770417766Bausch + LombBausch & Lomb IncorporatedJYE2025-08-08
00757770418695Bausch + LombBausch & Lomb IncorporatedJYE2025-08-08
00757770424078Bausch + LombBausch & Lomb IncorporatedJYE2025-08-08
00757770676439Bausch + LombBausch & Lomb IncorporatedJYE2025-08-05
00888515134157BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYE2024-02-28
00888515228177BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYE2024-02-28
00888515229013BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYE2024-02-28
00888515229020BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYE2024-02-28
00888515229099BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYE2024-02-28
00888515230033BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYE2024-02-28
00888515230040BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYE2024-02-28
00888515230057BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYE2024-02-28
00888515230064BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYE2024-02-28
G586E7214220Novo SurgicalNOVO SURGICAL, INC.JYE2023-12-18
G586E7214730Novo SurgicalNOVO SURGICAL, INC.JYE2023-12-18
00190776319052MillenniumAvalign Technologies, Inc.JYE2023-06-23
00840343716868GEN2SURGIX MEDICAL LLCJYE2023-06-02
00840343716875GEN2SURGIX MEDICAL LLCJYE2023-06-02
00840343716882GEN2SURGIX MEDICAL LLCJYE2023-06-02
14026704805157PILLINGTELEFLEX INCORPORATEDJYE2022-12-08
54026704805155PILLINGTELEFLEX INCORPORATEDJYE2022-12-08
00840343700607Gen2SURGIX MEDICAL LLCJYE2022-10-18
00887482039755Symmetry HouseASPEN SURGICAL PRODUCTS, INC.JYE2022-09-28
G277G2E9009630Gen2SURGIX MEDICAL LLCJYE2022-09-23
00190660008796Ambler SurgicalAMBLER SURGICAL CORP.JYE2021-01-07
00190660008802Ambler SurgicalAMBLER SURGICAL CORP.JYE2021-01-07
00190660008550Ambler SurgicalAMBLER SURGICAL CORP.JYE2021-01-04