FDA.reportPublic FDA data

NA

Primary DI
07613327354058
Brand
NA
Company
STRYKER CORPORATION
Model
6390
Catalog number
6390-600-000
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FZMSTOOL, OPERATING-ROOM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZMStool, Operating-RoomGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327354058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327354058076133273540587613327354058

GMDN Terms#

Term, Definition table
TermDefinition
Armboard, reusableA device designed to stabilize a patient's arm during an intervention or procedure typically to maintain the patency of an intravenous (IV) needle or an intravascular catheter. It is typically an elongated, flat surface of expanded polystyrene, wood, or artificial fibre board that is covered with a durable plastic or coating that can be easily cleaned. It may have a metal attachment so that it can be affixed to, e.g., an operating/examination table, a blood donor couch, or a chair, or it may be placed on a flat surface (e.g., on top of an operating/examination table). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078470558
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327524475Optablate97000151009700-015-1002022-09-23
07613327638233Omnicurve10320150001032-015-0002024-09-03
00857037006075LATERALATSYS24LATSYS242020-01-14
00857037006037LATERALATSYS20LATSYS202020-01-08
07613327060058Precision Ideal Eyes05028190100502-819-0102016-09-23
07613327006223ARIA48755700487557002019-11-20
07613327006919ES2 SPINAL SYSTEM48280082482800822019-11-20
07613327006926ES2 SPINAL SYSTEM48280083482800832019-11-20
07613327006940ES2 SPINAL SYSTEM48280086482800862019-11-20
07613327006957ES2 SPINAL SYSTEM48280087482800872019-11-20
07613327007114ES2 SPINAL SYSTEM48280311482803112019-11-25
07613327007558XIA 348237078482370782019-11-25
07613327007565XIA 348237079482370792019-11-25
07613327067088ACCULIF8003578003572016-09-24
07613327067095ACCULIF8003478003472016-09-24
07613327114799XIA 4.5 EVOLUTION48138140481381402019-11-21
07613327114812XIA 4.5 EVOLUTION48138011R48138011R2019-11-20
07613327114843XIA 4.5 EVOLUTION48138011L48138011L2019-11-20
07613327114850XIA 4.5 EVOLUTION48138101481381012019-11-21
07613327114874ES2 SPINAL SYSTEM48280178482801782019-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260647946109Doctor stool ak 445AKRUS GmbH & Co. KGFZM2026-06-22
04260647946116Doctor stool ak 446AKRUS GmbH & Co. KGFZM2026-06-22
04260647946123Doctor stool ak 447AKRUS GmbH & Co. KGFZM2026-06-22
04057027171257UFSK-OSYS Assistant's chairUFSK-International OSYS GmbHFZM2026-03-02
04057027349366UFSK-OSYS Assistant's chairUFSK-International OSYS GmbHFZM2026-03-02
04057027753217UFSK-OSYS Assistant's chairUFSK-International OSYS GmbHFZM2026-03-02
04057027768129UFSK-OSYS Assistant's chairUFSK-International OSYS GmbHFZM2026-03-02
04057027777473UFSK-OSYS Assistant's chairUFSK-International OSYS GmbHFZM2026-03-02
04057027896099UFSK-OSYS Assistant's chairUFSK-International OSYS GmbHFZM2026-03-02
04057027924617UFSK-OSYS Assistant's chairUFSK-International OSYS GmbHFZM2026-03-02
04057027958162UFSK-OSYS Transport- and relaxing chairUFSK-International OSYS GmbHFZM2026-03-02
04260647945492Doctor stool ak 445AKRUS GmbH & Co. KGFZM2025-11-28
04260647945508Doctor stool ak 445AKRUS GmbH & Co. KGFZM2025-11-28
04260647945522Doctor stool ak 445AKRUS GmbH & Co. KGFZM2025-11-28
04260647945546Doctor stool ak 445AKRUS GmbH & Co. KGFZM2025-11-28
04260647945553Doctor stool ak 445AKRUS GmbH & Co. KGFZM2025-11-28
04260647945577Doctor stool ak 445AKRUS GmbH & Co. KGFZM2025-11-28
04260647945584Doctor stool ak 445AKRUS GmbH & Co. KGFZM2025-11-28
04260647945591Doctor stool ak 445AKRUS GmbH & Co. KGFZM2025-11-28
04260647945607Doctor stool ak 445AKRUS GmbH & Co. KGFZM2025-11-28
04260647945652Doctor stool ak 445AKRUS GmbH & Co. KGFZM2025-11-28
04260647945669Doctor stool ak 445AKRUS GmbH & Co. KGFZM2025-11-28
04260647945676Doctor stool ak 445AKRUS GmbH & Co. KGFZM2025-11-28
04260647945683Doctor stool ak 445AKRUS GmbH & Co. KGFZM2025-11-28
04260647945690Doctor stool ak 446AKRUS GmbH & Co. KGFZM2025-11-28
04260647945713Doctor stool ak 446AKRUS GmbH & Co. KGFZM2025-11-28
04260647945720Doctor stool ak 447AKRUS GmbH & Co. KGFZM2025-11-28
04260647945737Doctor stool ak 447AKRUS GmbH & Co. KGFZM2025-11-28
04260647945751Doctor stool ak 447AKRUS GmbH & Co. KGFZM2025-11-28
04260647945768Doctor stool ak 447AKRUS GmbH & Co. KGFZM2025-11-28