FDA.reportPublic FDA data

DUAL DOT LABEL

Primary DI
50732224730719
Brand
DUAL DOT LABEL
Company
SPS Medical Supply Corp.
Model
DDL-010
Catalog number
DDL-010
Device description
Labels that provide a distinct color change when exposed to the appropriate sterilization process
Published
2016-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOJIndicator, physical/chemical sterilization process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOJIndicator, Physical/Chemical Sterilization ProcessGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K890763000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K890763000LABEL, STERILIZATION INDICATOR; DUAL STEAM/E.O.GASSpsmedical Supply Corp.1989-08-07JOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50732224730719PackageGS110In Commercial Distribution
10732224730711PrimaryGS10
00732224730714Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5073222473071950732224730719
1073222473071110732224730711
00732224730714007322247307147322247307140732224730714

GMDN Terms#

Term, Definition table
TermDefinition
Chemical/physical sterilization process indicatorA sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Controlled room temperature per USP
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(585)359-0130info@spsmedical.com

Regulatory Flags#

DUNS number
194877072
Device count
800
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10732224710041DRY HEAT INDICATOR STRIPDIS-100DIS-1002016-11-15
10732224710058CHEMICAL VAPOR INDICATORVIS-100VIS-1002016-11-15
10732224710065STEAM INDICATOR LABELSIL-1000SIL-10002016-11-15
10732224710072EO GAS INDICATOR LABELGIL-1000GIL-10002016-11-15
10732224710089DRY HEAT INDICATOR LABELDIL-1000DIL-10002016-11-15
10732224710102DUAL MONITOR STRIPDMS-250DMS-2502016-11-15
10732224710126Patient Record CardPRC-250PRC-2502016-11-15
10732224710140LANTOR CUBE BOWIE DICK TEST PACKLCR-025LCR-0252016-11-15
10732224710294EO GAS INDICATOR STRIPGIS-250GIS-2502016-11-15
10732224710317EO Gas Chemical Indicator StripsGIL-250GIL-2502016-11-15
10732224710348CHEMICAL VAPOR INDICATORVIS-250VIS-2502016-11-15
10732224710362DUAL MONITOR STRIP LAMINATEDDMS-250-LDMS-250-L2016-11-15
10732224710393Sterilization Chemical Indicator LabelsSGL-1000SGL-10002016-11-15
10732224710508STEAMPLUS STERILIZER TEST PACKSTP-025STP-0252016-11-15
10732224710522STEAM INDCTR STRIP LAMINATED LONGSIL-250-LSIL-250-L2016-11-15
10732224710553AIRVIEW BOWIE-DICK TEST PACKSBD-030SBD-0302016-11-15
10732224710775AirView II BOWIE-DICK TEST PACKMBD030MBD0302016-11-15
10732224730179STEAM TAPEST-072ST-0722016-11-15
10732224730186STEAM TAPEST-048ST-0482016-11-15
10732224730193STEAM TAPEST-036ST-0362016-11-15

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Primary DI, Brand, Company table
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