FDA.reportPublic FDA data

activL®

Primary DI
04038653431410
Brand
activL®
Company
Aesculap AG
Model
FW990R
Catalog number
FW990R
Device description
ACTIV L SINGLE CHISEL F/H10MM
Published
2017-05-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
04038653431410PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653431410040386534314104038653431410

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(888)229-3002setworld_orders@aesculap.com
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
315018218
Device count
1
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
M670107751700Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M670107751900Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M6709100000101Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M670910000021205Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M670910000021407Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M670910000021609Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M670910000022206Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M670910000022408Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M6709100000303Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M6709100000707Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M670910000080109Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000008020Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009150Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009160Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009250Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009260Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009350Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009360Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009450Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009460Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009550Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009560Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009650Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009660Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000010750Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000010760Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000010850Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000010860Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000010950Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000010960Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17