FDA.report

Stablyx

Primary DI
00841506100364
Brand
Stablyx
Company
SKELETAL DYNAMICS L.L.C.
Model
STABLYX CMC Arthroplasty System Sterilization Tray
Catalog number
STX-CMC-TRAY
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KCTSterilization wrap containers, trays, cassettes & other accessories

Product Code Classifications

CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841506100364PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841506100364008415061003648415061003640841506100364

GMDN Terms

TermDefinition
Sterilization/disinfection containerA receptacle designed to hold wrapped and/or unwrapped medical devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots for microsurgical instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(305)596-7585feedback@skeletaldynamics.com

Regulatory Flags

DUNS number
869056148
Device count
1
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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