Surgicutt Bleeding Time Device

Basic Information

• Brand Name: Surgicutt Bleeding Time Device
• Primary DI: 20711234304157
• Version / Model: SU50I
• Catalog Number: SU50I
• Company Name: ACCRIVA DIAGNOSTICS HOLDINGS, INC.
• Labeler DUNS: 079299318
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 6
• Public Version Date: 2023-05-12
• Public Version Status: Update
• Public Device Record Key: ad5eb7cd-5641-420d-8761-4134950c8b1b
• Distribution End Date: 2022-11-22

Device Description

Surgicutt Bleeding Time Device 50/box

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JCA	Device, Bleeding Time	Hematology	864.6100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61579	Blood lancet, single-use	A sterile, hand-held, sharply-pointed, non-mechanical, scalpel-like instrument intended to be used by a healthcare provider to manually puncture the skin of a patient to obtain a small blood specimen or drain a cyst or boil. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20711234304157	GS1
Unit of Use	00711234304153	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K850542	000

Device Sizes

Type	Value	Unit	Text
Length	5.00	Millimeter
Depth	1.00	Millimeter