FDA.reportPublic FDA data

AS Columbus® REVISION

Primary DI
04046963176938
Brand
AS Columbus® REVISION
Company
Aesculap AG
Model
NR060Z
Catalog number
NR060Z
Device description
AS COLUMBUS TIB.HEMI-SP.T5 5MM RM/LL
Published
2015-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046963176938PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046963176938040469631769384046963176938

GMDN Terms#

Term, Definition table
TermDefinition
Knee arthroplasty wedgeA sterile device designed to augment the implantation of a knee femur or tibia prosthesis by acting as a space-filler adjacent to the prosthesis, typically to replace lost bone. It is typically made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo) or titanium (Ti)].

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

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
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046964694165AESCULAPPL741SUPL741SU2016-09-23
04046964809392AESCULAPPL739SUPL739SU2016-10-10
04046964810411AESCULAPPL743SUPL743SU2016-10-10
04038653434022AESCULAPFT944TFT944T2015-09-24
04046963417468AESCULAPFT942TFT942T2015-09-24
04038653042586AESCULAPET251RET251R2016-09-23
04046964227547AESCULAPGF058BGF058B2016-09-23
04038653148998AESCULAPDO706RDO706R2020-04-21
04038653105878AESCULAPLS059RLS059R2020-04-21
04038653106080AESCULAPLS099RLS099R2020-04-21
04038653034666AESCULAPDE419RDE419R2020-06-17
04038653034697AESCULAPDE422RDE422R2020-06-17
04038653105977AESCULAPLS084RLS084R2022-07-29
04038653199020AESCULAPXG105RXG105R2021-10-15
04038653199006AESCULAPXG103RXG103R2020-08-24
04038653199013AESCULAPXG104RXG104R2020-08-24
04038653460533AESCULAPXG106RXG106R2020-08-24
04046963000431AESCULAPXG107RXG107R2020-08-24
04046963000448AESCULAPXG108RXG108R2020-08-24
04046963611538AESCULAPXG126RXG126R2020-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809945895311EXULT Special Instrument(CM)Corentec Co., LtdJWH2026-10-15
08809945895328EXULT Special Instrument(CM)Corentec Co., LtdJWH2026-10-15
08809945895335EXULT Special Instrument(CM)Corentec Co., LtdJWH2026-10-15
08809945895342EXULT Special Instrument(CM)Corentec Co., LtdJWH2026-10-15
08809945895359EXULT Special Instrument(CM)Corentec Co., LtdJWH2026-10-15
08809945895366EXULT Special Instrument(CM)Corentec Co., LtdJWH2026-10-15
08809945895373EXULT Special Instrument(CM)Corentec Co., LtdJWH2026-10-15
08809945895380EXULT Special Instrument(CM)Corentec Co., LtdJWH2026-10-15
08809945895397EXULT Special Instrument(CM)Corentec Co., LtdJWH2026-10-15
08809945895403EXULT Special Instrument(CM)Corentec Co., LtdJWH2026-10-15
08906067247247Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247254Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247261Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247278Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247285Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247292Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247308Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247315Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247322Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247339Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247346Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247353Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247360Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247377Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247384Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247391Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247407Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247414Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247421Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247438Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05