FDA.reportPublic FDA data

Excia®

Primary DI
04038653385560
Brand
Excia®
Company
Aesculap AG
Model
NC416T
Catalog number
NC416T
Device description
EXCIA PLASMAPORE-µCAP 8/10 SIZE 16MM
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
MEHProsthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653385560PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653385560040386533855604038653385560

GMDN Terms#

Term, Definition table
TermDefinition
Coated hip femur prosthesis, modularA sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
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

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 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
04038653177035AESCULAPOG963ROG963R2016-09-23
04038653242962AESCULAPDF262RDF262R2020-06-17
04038653339563AESCULAPJG901JG9012025-03-22
04038653345038AESCULAPJG910JG9102020-05-20
04038653038244AESCULAPDP511RDP511R2020-06-17
04038653038251AESCULAPDP512RDP512R2020-06-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862653697AlteonExactech, Inc.MEH2026-05-26
10885862653703AlteonExactech, Inc.MEH2026-05-26
10885862653710AlteonExactech, Inc.MEH2026-05-26
10885862653727AlteonExactech, Inc.MEH2026-05-26
10885862653734AlteonExactech, Inc.MEH2026-05-26
10885862653741AlteonExactech, Inc.MEH2026-05-26
10885862653758AlteonExactech, Inc.MEH2026-05-26
10885862653765AlteonExactech, Inc.MEH2026-05-26
10885862653772AlteonExactech, Inc.MEH2026-05-26
10885862653789AlteonExactech, Inc.MEH2026-05-26
10885862653796AlteonExactech, Inc.MEH2026-05-26
10885862653802AlteonExactech, Inc.MEH2026-05-26
10885862653819AlteonExactech, Inc.MEH2026-05-26
10885862653826AlteonExactech, Inc.MEH2026-05-26
10885862653833AlteonExactech, Inc.MEH2026-05-26
10885862653840AlteonExactech, Inc.MEH2026-05-26
10885862653857AlteonExactech, Inc.MEH2026-05-26
10885862653864AlteonExactech, Inc.MEH2026-05-26
10885862653871AlteonExactech, Inc.MEH2026-05-26
10885862653888AlteonExactech, Inc.MEH2026-05-26
10885862653895AlteonExactech, Inc.MEH2026-05-26
10885862653901AlteonExactech, Inc.MEH2026-05-26
10885862653918AlteonExactech, Inc.MEH2026-05-26
10885862653925AlteonExactech, Inc.MEH2026-05-26
10885862653932AlteonExactech, Inc.MEH2026-05-26
10885862653949AlteonExactech, Inc.MEH2026-05-26
10885862653956AlteonExactech, Inc.MEH2026-05-26
10885862653963AlteonExactech, Inc.MEH2026-05-26
10885862653970AlteonExactech, Inc.MEH2026-05-26
10885862653987AlteonExactech, Inc.MEH2026-05-26