N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00810047421153
• Version / Model: 9804-02
• Company Name: Scientific Device Laboratory, Inc.
• Labeler DUNS: 115927956
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-31
• Public Version: 1
• Public Version Date: 2023-02-08
• Public Version Status: New
• Public Device Record Key: f7a09d84-a293-4591-9395-2b42351e6671

Device Description

Aqua Hold II [each]

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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	862.2050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63038	Microscope slide barrier-ink pen IVD	A hand-held pen intended to be used to circumscribe a microscope-slide-mounted tissue specimen with water-repellent ink to contain fluids (e.g., washing buffer, antibody solution, chromogenic substrates) applied to the specimen during manual processing and/or staining procedures.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810047421153	GS1