DRY HEAT INDICATOR LABEL DTL-125

GUDID 10732224710409

Labels that provide a distinct color change when exposed to the appropriate sterilization process

SPS Medical Supply Corp.

Chemical/physical sterilization process indicator
Primary Device ID10732224710409
NIH Device Record Keya4cc6955-2002-4804-87ab-4c702b5e3f78
Commercial Distribution StatusIn Commercial Distribution
Brand NameDRY HEAT INDICATOR LABEL
Version Model NumberDTL-125
Catalog NumberDTL-125
Company DUNS194877072
Company NameSPS Medical Supply Corp.
Device Count125
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(585)359-0130
Emailinfo@spsmedical.com
Phone+1(585)359-0130
Emailinfo@spsmedical.com
Phone+1(585)359-0130
Emailinfo@spsmedical.com
Phone+1(585)359-0130
Emailinfo@spsmedical.com
Phone+1(585)359-0130
Emailinfo@spsmedical.com
Phone+1(585)359-0130
Emailinfo@spsmedical.com
Phone+1(585)359-0130
Emailinfo@spsmedical.com
Phone+1(585)359-0130
Emailinfo@spsmedical.com
Phone+1(585)359-0130
Emailinfo@spsmedical.com
Phone+1(585)359-0130
Emailinfo@spsmedical.com
Phone+1(585)359-0130
Emailinfo@spsmedical.com
Phone+1(585)359-0130
Emailinfo@spsmedical.com
Phone+1(585)359-0130
Emailinfo@spsmedical.com
Phone+1(585)359-0130
Emailinfo@spsmedical.com
Phone+1(585)359-0130
Emailinfo@spsmedical.com
Phone+1(585)359-0130
Emailinfo@spsmedical.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Controlled room temperature per USP
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Controlled room temperature per USP
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Controlled room temperature per USP
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Controlled room temperature per USP
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Controlled room temperature per USP
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Controlled room temperature per USP
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Controlled room temperature per USP
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Controlled room temperature per USP
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Controlled room temperature per USP
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Controlled room temperature per USP
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Controlled room temperature per USP
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Controlled room temperature per USP
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Controlled room temperature per USP
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Controlled room temperature per USP
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Controlled room temperature per USP
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Controlled room temperature per USP

Device Identifiers

Device Issuing AgencyDevice ID
GS100732224710402 [Unit of Use]
GS110732224710409 [Primary]

FDA Product Code

JOJIndicator, physical/chemical sterilization process

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-02-19
Device Publish Date2016-11-15

On-Brand Devices [DRY HEAT INDICATOR LABEL]

10732224710409Labels that provide a distinct color change when exposed to the appropriate sterilization proces
50732224710087Labels that provide a distinct color change when exposed to the appropriate sterilization proces

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.