FDA.report

AESCULAP

Primary DI
04038653037599
Brand
AESCULAP
Company
Aesculap AG
Model
DO722R
Catalog number
DO722R
Device description
EAST GRINSTEAD/WARD CHISEL 3MM 180MM
Published
2020-04-20
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

Related Records

Contact Domains

Product Codes

CodeName
EMMCHISEL, OSTEOTOME, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
EMMChisel, Osteotome, SurgicalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04038653037599PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04038653037599040386530375994038653037599

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

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

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04038653034369AESCULAPDE116RDE116R2020-06-17
04038653034376AESCULAPDE117RDE117R2020-06-17
04038653034406AESCULAPDE120RDE120R2020-06-17
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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 DIBrandCompanyProduct codePublished
04251436931086KOHLERKohler Medizintechnik GmbHEMM2026-03-12
00841013120572Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMM2026-01-06
00841013120589Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMM2026-01-06
00841013120596Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMM2026-01-06
D9282001491H0OSTEOTOME, 7", 4mm SLIGHT CURVE MARKINGS 12-9-6-3mm, HEXED HANDLEW.H. Holden, Inc.EMM2026-01-06
D9282001492H0OSTEOTOME, 7", 4mm, STRONG CURVE, HEXED HANDLEW.H. Holden, Inc.EMM2026-01-06
D9282001493H0OSTEOTOME, 7", 4mm, OFFSET, HEXED HANDLEW.H. Holden, Inc.EMM2026-01-06
D928200149H0OSTEOTOME, 7", 4mm STRAIGHT, MARKINGS 12-9-6-3mm, HEXED HANDLEW.H. Holden, Inc.EMM2026-01-06
D9282001501H0OSTEOTOME, 7", 6mm, SLIGHT CURVE, HEXED HANDLEW.H. Holden, Inc.EMM2026-01-06
D9282001502H0OSTEOTOME, 7", 6mm, STRONG CURVE, HEXED HANDLEW.H. Holden, Inc.EMM2026-01-06
D9282001503H0OSTEOTOME, 7", 6mm, OFFSET, HEXED HANDLEW.H. Holden, Inc.EMM2026-01-06
D928200150H0OSTEOTOME, 7", 6mm, STRAIGHT, HEXED HANDLEW.H. Holden, Inc.EMM2026-01-06
00841336106260Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMM2025-11-11
00190776401306MillenniumAvalign Technologies, Inc.EMM2025-06-10
D92820029090BURTON PTERYGOID OSTEOTOME 9MMW.H. Holden, Inc.EMM2025-05-21
00190776394646MillenniumAvalign Technologies, Inc.EMM2025-05-07
G586NS38796080NOVOSURGICALNOVO SURGICAL, INC.EMM2025-05-02
00194613108656MSI Precision Specialty InstrumentsMed Saver, Inc.EMM2025-03-21
D928105382010BONE CHISEL 2.5MM, 6" S/EW.H. Holden, Inc.EMM2025-03-19
D928105382020BONE CHISEL 4MM, 6" S/EW.H. Holden, Inc.EMM2025-03-19
EZPF2474485HZU0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMM2025-03-07
EZPF4774831HZU0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMM2025-03-07
EZPF4774841HZU0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMM2025-03-07
D9281675060MINI-LEXER, OSTEOTOME 6mm, STRAIGHTW.H. Holden, Inc.EMM2024-12-18
D9281675080MINI-LEXER, OSTEOTOME 8mm, STRAIGHTW.H. Holden, Inc.EMM2024-12-18
D9281675100MINI-LEXER, OSTEOTOME 10mm STRAIGHTW.H. Holden, Inc.EMM2024-12-18
D9281676060MINI-LEXER, GOUGE 6mmW.H. Holden, Inc.EMM2024-12-18
D9281676080MINI-LEXER, GOUGE 8mmW.H. Holden, Inc.EMM2024-12-18
D9281676100MINI-LEXER, GOUGE 10mmW.H. Holden, Inc.EMM2024-12-18
D9281790900IDR KIT ACCORDING TO DR. ROSAW.H. Holden, Inc.EMM2024-12-18