FDA.reportPublic FDA data

Recapper RC1200 Olympus, 115V

Primary DI
04038917238250
Brand
Recapper RC1200 Olympus, 115V
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
90.197.011
Catalog number
90.197.011
Published
2022-11-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXGEQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038917238250PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038917238250040389172382504038917238250

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory container/microscope slide robotic transfer system IVDAn assembly of electrically-powered robotic devices, a stand-alone device, or a belt conveyor intended to be used for the automated or semi-automated transfer of assay containers (e.g., test tubes, microplates), microscope slides/slide carriers, or racks between processing stations. The system may interface with individual instruments/analysers and other equipment, transporting assay containers between stations which may include specimen pipetting, reagent dispensing, incubation, microplate washing, agitation, barcode reading and/or optical reading.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)257-5101customerservice.us@sarstedt.com

Regulatory Flags#

DUNS number
388000270
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04038917125154S-Monovette®02.1066.00102.1066.0012016-09-16
04038917125260S-Monovette®03.1068.10003.1068.1002016-09-16
04038917126243S-Monovette®05.1167.12005.1167.1202016-09-16
04038917131957S-Monovette®01.1605.00101.1605.0012016-09-16
04038917132039S-Monovette®01.1605.10001.1605.1002016-09-16
04038917132824S-Monovette®06.1664.10006.1664.1002016-09-16
04038917134170S-Monovette®04.1901.10004.1901.1002016-09-16
04038917134361S-Monovette®04.1914.10004.1914.1002016-09-16
04038917134514S-Monovette®04.1931.10004.1931.1002016-09-16
04038917134521S-Monovette®04.1932.00104.1932.0012016-09-16
04038917238526S-Monovette®04.1917.10004.1917.1002016-09-16
04038917322737S-Monovette®06.1660.10006.1660.1002017-06-20
04038917350334S-Monovette®02.1066.10002.1066.1002016-09-16
04038917361668S-Monovette®05.1081.10005.1081.1002016-09-16
04038917370196S-Monovette®04.1931.01304.1931.0132016-09-16
04038917382250S-Monovette®04.1915.10004.1915.1002018-01-03
04038917311472RC 1200 S13 Hitachi, 115 V90.197.20190.197.2012022-11-30
04038917317658RC 1200 S 15 Hitachi, 115V90.197.10190.197.1012022-11-30
04038917536783DC 1200, Decapper Eurolab,115V90.198.51890.198.5182022-11-30
04038917546904RC 1200 Olympus AU5800, 115V90.197.03690.197.0362022-11-30

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Primary DI, Brand, Company table
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04038917124614TUBE SEGMENT OPENER ASM TB 75/12 PSSarstedt Aktiengesellschaft & Co.KGLXG2026-07-21
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15099590812478DxUBeckman Coulter, Inc.LXG2026-06-24
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00810100050269KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050283KBMEDKB Medical (group), Inc.LXG2025-05-22
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00810100050511KBMEDKB Medical (group), Inc.LXG2025-05-22
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