BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

Steam Autoclave Tape

DI: M985CISTP121 · Model: 12mm · MESA LABORATORIES, INC.

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

72

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Basic Information

Brand Name: Steam Autoclave Tape
Primary DI: M985CISTP121
Version / Model: 12mm
Catalog Number: CI-STP-12
Company Name: MESA LABORATORIES, INC.
Labeler DUNS: 102530326
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 72
Record Status: Published
Publish Date: 2016-08-29
Public Version: 3
Public Version Date: 2018-07-06
Public Version Status: Update
Public Device Record Key: d04ba73f-79b5-46e8-b7ba-3520ed562a5d
Distribution End Date: 2016-08-30

Device Description

12mm autoclave tape

Device Characteristics

Single Use: Yes
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: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: Yes
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
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	880.2800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13732	Biological sterilization indicator	A sterilization indicator consisting of a standardized, viable population of microorganisms (e.g., bacterial spores known to be resistant to the mode of sterilization being monitored) that will display a change when exposed to an effective sterilization outcome indicating that sterilization parameters have been met. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M985CISTP121	HIBCC
Unit of Use	M985CISTP120	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K080307	000