FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653327157
Brand
AESCULAP
Company
Aesculap AG
Model
FJ985R
Catalog number
FJ985R
Device description
APFELBAUM C1-2 INNER SLEEVE GUIDE
Published
2016-10-10
Public version status
Update
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
OLOOrthopedic stereotaxic instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653327157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653327157040386533271574038653327157

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(888)229-3002setworld_orders@aesculap.com
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
315018218
Device count
1
DM exempt
true
Premarket exempt
false
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
00193982622312EXCELSIUSGPSGLOBUS MEDICAL, INC.OLO2026-03-24
00193982622329EXCELSIUSGPSGLOBUS MEDICAL, INC.OLO2026-03-24
00199150024469INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-03-22
00199150024483INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-03-22
00199150038138INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-03-21
00885556919712Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556919729Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556919743Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556919750Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556919767Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556919774Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556924198Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556924204Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556924211Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556924228Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556924235Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556924242Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556924266Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556924273Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556924297Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
20885556924307NASmith & Nephew, Inc.OLO2026-03-10
07613327627725MakoMAKO SURGICAL CORP.OLO2026-03-10
00840493413228RIVA Posterior Fixation SystemXENIX MEDICAL LLCOLO2026-03-03
07613327683653Shoulder 1.5 Installation DiskMAKO SURGICAL CORP.OLO2026-03-03
10888857563384Q Interbody InstrumentsK2M, INC.OLO2026-03-03
10888857563391Q Interbody InstrumentsK2M, INC.OLO2026-03-03
10888857563407Q Interbody InstrumentsK2M, INC.OLO2026-03-03
10888857563414Q Interbody InstrumentsK2M, INC.OLO2026-03-03
10888857563421Q Interbody InstrumentsK2M, INC.OLO2026-03-03
10888857578876Q Interbody InstrumentsK2M, INC.OLO2026-03-03