ACTIV C

Primary DI: 04046963780128
Brand: ACTIV C
Company: Aesculap AG
Model: FW782R
Catalog number: FW782R
Device description: ACTIV C FORK 6MM F/IMPACTOR FW783R
Published: 2020-04-24
Public version status: New
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: true
OTC: false
Sterile: false
Single use: false

Related Records

Contact Domains

Product Codes

Code	Name
HXE	FORK

Product Code Classifications

Code	Device	Specialty	Class
HXE	Fork	Orthopedic	1

Identifiers And Packaging

Identifier	Type	Agency	Package quantity	Status
04046963780128	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier	GTIN-14 normalized	EAN-13
04046963780128	04046963780128	4046963780128

GMDN Terms

Term	Definition
Orthopaedic prosthesis implantation instrument, reusable	A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Term

Definition

Orthopaedic prosthesis implantation instrument, reusable

A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

Phone	Email
+1(888)229-3002	setworld_orders@aesculap.com
+1(800)282-9000	GUDID.BBMUS_Service@bbraun.com

Regulatory Flags

DUNS number: 315018218
Device count: 1
DM exempt: false
Premarket exempt: true
HCT/P: false
Kit: false
Combination product: false
Lot or batch: true
Serial number: false
Manufacturing date on label: false
Expiration date on label: false
Donation ID number: false
Contains natural rubber latex: false
No natural rubber latex: false
Sterilization required before use: true

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