FDA.reportPublic FDA data

Container, Sterilization, plastic complete, 502x239x102mm

Primary DI
04057034179383
Brand
Container, Sterilization, plastic complete, 502x239x102mm
Company
Geister Medizintechnik GmbH
Model
77-3605
Catalog number
77-3605
Device description
Container, Sterilization, plastic complete, 502x239x102mm ValveGate™, SurgiBOX™ Plastic
Published
2023-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
04057034179383PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04057034179383040570341793834057034179383

GMDN Terms#

Term, Definition table
TermDefinition
Sterilizer/disinfector rack instrument-holding insert, reusableA device intended to be fitted into the rack/container/tray of a sterilizer or disinfector to hold, position, and sometimes protect a medical/surgical instrument(s) during a sterilization and/or disinfection procedure. It may be available in various forms including a plug-like cone with a hollow centre for instrument placement. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+497461966240info@geister.com

Regulatory Flags#

DUNS number
343548848
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04057034294543Punch, acc. Kerrison, K-Rex™ 40° upwards 18cm 1mm,w.ejector40-3218C140-3218C12026-05-26
04057034047958DeBakey Vascular Dilator 19cm 6.0mm21-0207.JR21-0207.JR2023-10-11
04057034047965Dilator, Vascular, acc. DeBakey 19cm 6.0mm21-0207.SI21-0207.SI2023-10-11
04057034292327Dilator, Vascular, acc. DeBakey 19cm 6.0mm #Custom-made product#21-0207.NI21-0207.NI2023-10-11
04057034047484Garret Garrett Vessel Probe Holders 21cm21-015621-01562023-09-29
04057034047491Dilator, Vascular, acc. Garrett, set 35cm (12 sizes 0.5-9.0mm)21-016021-01602023-09-29
04057034047507Dilator, Vascular, acc. Garrett 35cm 0.5mm21-016121-01612023-09-29
04057034047514Dilator, Vascular, acc. Garrett 35cm 1.0mm21-016221-01622023-09-29
04057034047521Dilator, Vascular, acc. Garrett 35cm 1.5mm21-016321-01632023-09-29
04057034047538Dilator, Vascular, acc. Garrett 35cm 2.0mm21-016421-01642023-09-29
04057034047545Dilator, Vascular, acc. Garrett 35cm 2.5mm21-016521-01652023-09-29
04057034047552Dilator, Vascular, acc. Garrett 35cm 3.0mm21-016621-01662023-09-29
04057034047569Dilator, Vascular, acc. Garrett 35cm 3.5mm21-016721-01672023-09-29
04057034047576Dilator, Vascular, acc. Garrett 35cm 4.0mm21-016821-01682023-09-29
04057034047583Dilator, Vascular, acc. Garrett 35cm 4.5mm21-016921-01692023-09-29
04057034047590Dilator, Vascular, acc. Garrett 35cm 5.0mm21-017021-01702023-09-29
04057034047606Dilator, Vascular, acc. Garrett 35cm 7.0mm21-017121-01712023-09-29
04057034047613Dilator, Vascular, acc. Garrett 35cm 9.0mm21-017221-01722023-09-29
04057034047651Dilator, Vascular, acc. DeBakey 19cm 0.5mm21-019921-01992023-09-29
04057034047668Dilator, Vascular, acc. DeBakey 19cm 0.5mm21-0199.SI21-0199.SI2023-09-29

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