US IVD 48 Spot Target

Basic Information

• Brand Name: US IVD 48 Spot Target
• Primary DI: 00841594110054
• Version / Model: 8604532
• Catalog Number: 8604532
• Company Name: Bruker Scientific LLC
• Labeler DUNS: 877298661
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 6
• Public Version Date: 2022-09-26
• Public Version Status: Update
• Public Device Record Key: 1d604784-9a1b-4bd9-bfd4-3809f4dd874e
• Distribution End Date: 2019-05-31

Device Description

Reuseable Stainless Steel Target.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Peracetic Acid

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PEX	System, mass spectrometry, maldi tof, microorganism identification, cultured isolates	Microbiology	866.3361	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61296	Microplate IVD	A plate with multiple wells designed to contain small volumes of clinical specimens, reagents, or other materials for testing procedures performed by a laboratory analyser. It is typically made of sterilizable plastic material (e.g., polypropylene) and is used with manual or automated analysers. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10841594110020	GS1	Pack	5	Not in Commercial Distribution	2019-05-31
Primary	00841594110054	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]