FDA.report

AS ENDURO

Primary DI
04046963937300
Brand
AS ENDURO
Company
Aesculap AG
Model
NR376Z
Catalog number
NR376Z
Device description
AS ENDURO FEM.SPACER POST/DIST F2 4X4MM
Published
2015-09-24
Public version status
Update
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
KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Product Code Classifications

CodeDeviceSpecialtyClass
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046963937300PrimaryGS10

Alternate GTIN/UPC/EAN values are derived from GS1 digit structure for lookup convenience. Do not treat derived UPC-A or EAN-13 values as separate FDA identifiers. GTIN-14 values with indicator digits 1-9 usually represent packaging levels, cases, pallets, or variable-measure items and are not converted to UPC-A/EAN-13 here.

Alternate GTIN / UPC / EAN Codes

Source identifierSource lengthGTIN-14 normalizedIndicatorEAN-13Conversion note
04046963937300140404696393730004046963937300Indicator 0 allows EAN-13 conversion; UPC-A requires prefix 00.

GMDN Terms

TermDefinition
Knee arthroplasty wedgeAn implantable device designed to augment the implantation of a knee femur or tibia prosthesis by serving as a space-filler adjacent to the prosthesis, typically to replace lost bone and increase bone contact area and aid stability. It is typically made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo) or titanium (Ti)].

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+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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00889024702011OSS™ Orthopedic Salvage SystemBiomet Orthopedics, LLCKRO2025-12-05
00889024702028OSS™ Orthopedic Salvage SystemBiomet Orthopedics, LLCKRO2025-12-05
00889024703285OSS™ Orthopedic Salvage SystemBiomet Orthopedics, LLCKRO2025-12-02
00889024703322OSS™ Orthopedic Salvage SystemBiomet Orthopedics, LLCKRO2025-12-02
04719872142812USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-11
04719872142829USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KRO2025-09-11
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