FDA.reportPublic FDA data

activL®

Primary DI
04038653431359
Brand
activL®
Company
Aesculap AG
Model
FW984R
Catalog number
FW984R
Device description
ACTIV L CHISEL GUIDE F/H14MM 6°
Published
2017-05-15
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
QLQManual instruments designed for use with total disc replacement devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QLQManual Instruments Designed For Use With Total Disc Replacement DevicesOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653431359PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653431359040386534313594038653431359

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation 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. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface 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
false
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
03662663083478ActivLHighridge Medical, LLCQLQ2026-02-03
03662663083485ActivLHighridge Medical, LLCQLQ2026-02-03
03662663083515ActivLHighridge Medical, LLCQLQ2026-02-03
03662663083751ActivLHighridge Medical, LLCQLQ2026-02-03
03662663083768ActivLHighridge Medical, LLCQLQ2026-02-03
03662663083775ActivLHighridge Medical, LLCQLQ2026-02-03
03662663084215ActivLHighridge Medical, LLCQLQ2026-02-03
03662663084253ActivLHighridge Medical, LLCQLQ2026-02-03
03662663084277ActivLHighridge Medical, LLCQLQ2026-02-03
03662663084307ActivLHighridge Medical, LLCQLQ2026-02-03
03662663084314ActivLHighridge Medical, LLCQLQ2026-02-03
03662663084321ActivLHighridge Medical, LLCQLQ2026-02-03
03662663084338ActivLHighridge Medical, LLCQLQ2026-02-03
00812388032517M6-CSpinal Kinetics, Inc.QLQ2024-09-09
00812388032524M6-CSpinal Kinetics, Inc.QLQ2024-09-09
00812388032531M6-CSpinal Kinetics, Inc.QLQ2024-09-09
00812388032548M6-CSpinal Kinetics, Inc.QLQ2024-09-09
00812388032555M6-CSpinal Kinetics, Inc.QLQ2024-09-09
00812388032562M6-CSpinal Kinetics, Inc.QLQ2024-09-09
00812388032579M6-CSpinal Kinetics, Inc.QLQ2024-09-09
00812388032586M6-CSpinal Kinetics, Inc.QLQ2024-09-09
00812388032593M6-CSpinal Kinetics, Inc.QLQ2024-09-09
00812388032609M6-CSpinal Kinetics, Inc.QLQ2024-09-09
00812388032616M6-CSpinal Kinetics, Inc.QLQ2024-09-09
00812388032623M6-CSpinal Kinetics, Inc.QLQ2024-09-09
03662663059152Mobi-C Plug & Fit USLDR Spine Usa, Inc.QLQ2024-01-12
03662663000802Mobi-C Plug & Fit USZIMMER BIOMET INCQLQ2023-10-05
03662663000901Mobi-C Plug & Fit USZIMMER BIOMET INCQLQ2023-10-05
03662663000956Mobi-C Plug & Fit USZIMMER BIOMET INCQLQ2023-10-05
03662663001052Mobi-C Plug & Fit USZIMMER BIOMET INCQLQ2023-10-05