FDA.report

activL®

Primary DI
04038653425907
Brand
activL®
Company
Aesculap AG
Model
SW992K
Catalog number
SW992K
Device description
ACTIV L SUP.PLATE SIZE L 11°/SPIKES
Published
2015-10-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
04038653425907PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04038653425907040386534259074038653425907

GMDN Terms

TermDefinition
Lumbar total intervertebral disc replacement prosthesisAn implantable device designed to replace most or all of a dysfunctional intervertebral disc in the lumbar spine. It is typically made of metal or synthetic polymer 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

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