FDA.reportPublic FDA data

AESCULAP

Primary DI
05055049000608
Brand
AESCULAP
Company
AESCULAP, INC.
Model
US905
Catalog number
US905
Device description
ETO STERILIZATION LOCKS GREEN
Published
2016-09-22
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
KCTSterilization wrap containers, trays, cassettes & other accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055049000608PrimaryGS10
05055049091910Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055049000608050550490006085055049000608
05055049091910050550490919105055049091910

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 (non-electrical) 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, Specify00
Special Storage Condition, Specify00Avoid extreme temperature
Special Storage Condition, Specify00KEEP AWAY FROM SUNLIGHT
Special Storage Condition, Specify00Store in a cool place
Special Storage Condition, Specify00Store in a dry place
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
082594540
Device count
1000
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
04046964676628AESCULAPUS399US3992016-09-22
04046964256967AESCULAPUS910US9102016-09-22
05055049007423AESCULAPUS906US9062016-09-22
04046955074624AESCULAPFF025RFF025R2019-04-30
04046955074631AESCULAPFF026RFF026R2019-04-30
04046955074648AESCULAPFF027RFF027R2019-04-30
04046955074655AESCULAPFF028RFF028R2019-04-30
04046955074662AESCULAPFF029RFF029R2019-04-30
04046955074716AESCULAPFF086RFF086R2019-04-30
04046955074723AESCULAPFF087RFF087R2019-04-30
04046955074730AESCULAPFF088RFF088R2019-04-30
04046955074792AESCULAPFF136RFF136R2019-04-30
04046955074808AESCULAPFF137RFF137R2019-04-30
04046955074815AESCULAPFF138RFF138R2019-04-30
04046955074822AESCULAPFF690RFF690R2019-04-30
04046955074914AESCULAPFF828RFF828R2019-04-30
04046955074921AESCULAPFF829RFF829R2019-04-30
04046955074938AESCULAPFF830RFF830R2019-04-30
04046955074945AESCULAPFF831RFF831R2019-04-30
04046955074952AESCULAPFF841RFF841R2019-04-30

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