FDA.reportPublic FDA data

Compact Steri-Container

Primary DI
D68550Z905O0
Brand
Compact Steri-Container
Company
ZIRC DENTAL PRODUCTS, INC.
Model
O-N.Yellow
Catalog number
50Z905O
Device description
Instrument holder intended to hold 8-12 dental instruments together through the sterilization process.
Published
2018-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D68550Z905O0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, reusableA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
064783913
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00840161311900Airway Armor® - Throat Guard - Medium - 1 Count5Z960MD2026-05-01
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00840161307132Mr. Thirsty® One-Step - High Volume Evacuator - Medium5Z989MD2026-04-30
00840161311887Mr. Thirsty® One-Step - High Volume Evacuator - Small5Z989SM2026-04-30
00840161311948Crystal HD® Mouth Mirrors50Z384SMPL2026-04-27
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10840161304794Airway Armor®50Z960SM2022-10-07
10840161304800Airway Armor®50Z960MD2022-10-07
10840161304817Airway Armor®50Z960LG2022-10-07
00840161304797Airway Armor® - Throat Guard - Small - 25 Count50Z960SM2026-04-07
00840161304803Airway Armor® - Throat Guard - Medium - 25 Count50Z960MD2026-04-07
00840161304810Airway Armor® - Throat Guard - Large - 25 Count50Z960LG2026-04-07
60840161307110Mr. Thirsty® One-Step - Large (with 10mm and 16mm Adaptors) - 50 Count50Z989LG10/162026-04-08
60840161307134Mr. Thirsty® One-Step - Medium (with 10mm and 16mm Adaptors) - 50 Count50Z989MD10/162026-04-08
60840161307158Mr. Thirsty® One-Step - Small (with 10mm and 16mm Adaptors) - 50 Count50Z989SM10/162026-04-08
70840161307117Mr. Thirsty® One-Step - Large (with 10mm and 16mm Adaptors) - 100 Count50Z989LG-B10/162026-04-08
70840161307131Mr. Thirsty® One-Step - Medium (with 10mm and 16mm Adaptors) - 100 Count50Z989MD-B10/162026-04-08
70840161307155Mr. Thirsty® One-Step - Small (with 10mm and 16mm Adaptors) - 100 Count50Z989SM-B10/162026-04-08

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