FDA.report

Angle rotor

Primary DI
04050674084918
Brand
Angle rotor
Company
Andreas Hettich GmbH & Co. KG
Model
24-place
Catalog number
1552
Device description
Centrifuge rotor fixed angle, 24-place
Published
2021-09-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GKGCentrifuge, Hematocrit

Product Code Classifications

CodeDeviceSpecialtyClass
GKGCentrifuge, HematocritHematology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04050674084918PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04050674084918040506740849184050674084918

GMDN Terms

TermDefinition
Centrifuge rotor, fixed angleA device, commonly called the rotor, or rotor head, used as a component in a centrifuge. It is designed with the tube holding bores formed at a pre-set angle and pattern. It is horizontally attached at the top of the vertical shaft which is part of the electrically-powered drive unit and the samples to be centrifuged are placed in this rotor.

Sterilization Methods

Method

Regulatory Flags

DUNS number
316403245
Device count
1
DM exempt
false
Premarket exempt
true
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

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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
008318290004583D Printed Disp. Tube Holders (for HemataSTAT, Cream 50/pkg)SEPARATION TECHNOLOGY, INC.GKG2023-11-06
00840095655699Globe ScientificGLOBE SCIENTIFIC INC.GKG2023-07-05
00664816005309LW Scientific, Inc.LW SCIENTIFIC, INC.GKG2022-10-25
00664816005576LW Scientific, Inc.LW SCIENTIFIC, INC.GKG2022-09-09
00664816005613LW Scientific, Inc.LW SCIENTIFIC, INC.GKG2022-09-09
40612479200102McKessonMCKESSON MEDICAL-SURGICAL INC.GKG2022-08-31
00304040043370Henry ScheinHENRY SCHEIN, INC.GKG2022-04-22
00831829000410HemataSTAT II Centrifuge SEPARATION TECHNOLOGY, INC.GKG2022-03-31
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