FDA.report

ACTIV L

Primary DI
04038653431007
Brand
ACTIV L
Company
Aesculap AG
Model
SW975K
Catalog number
SW975K
Device description
ACTIV L SUP.PLATE SIZE S 11°/KEEL
Published
2020-03-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MJOProsthesis, intervertebral disc

Product Code Classifications

CodeDeviceSpecialtyClass
MJOProsthesis, Intervertebral DiscUnknown3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04038653431007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04038653431007040386534310074038653431007

GMDN Terms

TermDefinition
Lumbar total disc replacement prosthesisA sterile implantable device designed to replace most or all of a dysfunctional intervertebral disc in the lumbar spine. It is typically made of metal or plastic-like (biopolymer) materials, or a combination of the two. It most commonly has a two-plate design, one plate attaching to the vertebra above and the other to the vertebra below. The device is intended to facilitate motion usually through the sliding action of its smooth surfaces.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04038653177035AESCULAPOG963ROG963R2016-09-23
04038653242962AESCULAPDF262RDF262R2020-06-17
04038653339563AESCULAPJG901JG9012025-03-22
04038653345038AESCULAPJG910JG9102020-05-20
04038653038244AESCULAPDP511RDP511R2020-06-17
04038653038251AESCULAPDP512RDP512R2020-06-17
04038653038282AESCULAPDP540RDP540R2020-06-17
04038653038299AESCULAPDP541RDP541R2020-06-17
04038653038305AESCULAPDP542RDP542R2020-06-17
04038653177011AESCULAPOG961ROG961R2016-09-23
04038653251407AESCULAPOG960ROG960R2016-09-23
04038653044207MIASPAS MINI-ALIFFF569RFF569R2020-06-17
04038653044214MIASPAS MINI-ALIFFF571RFF571R2020-06-17
04038653044252MIASPAS MINI-ALIFFF578RFF578R2020-06-17
04038653044283MIASPAS MINI-ALIFFF586RFF586R2020-06-17
04038653117307AESCULAPNH196NH1962017-01-27
04038653117352AESCULAPNH206NH2062017-01-27
04038653118540AESCULAPNK088NK0882015-11-11
04038653118557AESCULAPNK089NK0892015-09-24
04038653118564AESCULAPNK090NK0902015-09-24

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