BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

Guide Pin 10 mm

DI: 09321502015790 · Model: 90794 · Cochlear Bone Anchored Solutions AB

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: Guide Pin 10 mm
Primary DI: 09321502015790
Version / Model: 90794
Catalog Number: 90794
Company Name: Cochlear Bone Anchored Solutions AB
Labeler DUNS: 559784736
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2017-06-07
Public Version: 5
Public Version Date: 2020-12-21
Public Version Status: Update
Public Device Record Key: dd2d0544-479a-40f3-bda5-2964758dbc90

Device Description

Laboratory component for prior generation Vistafix

Device Characteristics

Single Use: No
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: Yes
Has Expiration Date: No
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FZE	PROSTHESIS, NOSE, INTERNAL	General, Plastic Surgery	878.3680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61467	General external orthopaedic fixation system implantation kit, single-use	A collection of non-sterile, manual surgical instruments intended to be used for the placement of an external orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It includes various instruments [e.g., retractors, rods, clamps, drills, pins/screws, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of external orthopaedic fixation system (i.e., non-dedicated); it does not include any implantable devices. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09321502015790	GS1

Customer Contacts

Phone: +1(800)523-5798
Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			10 mm long guide pin
Length	10	Millimeter

Storage Conditions

Type: Special Storage Condition, Specify
Special Conditions: Store at room temperature