FDA.report

Smeed Technologies

Primary DI
00850059853016
Brand
Smeed Technologies
Company
Smeed Technologies LLC
Model
ST-MERK-01_02
Published
2024-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FOXStand, Infusion

Product Code Classifications

CodeDeviceSpecialtyClass
FOXStand, InfusionGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850059853016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850059853016008500598530168500598530160850059853016

GMDN Terms

TermDefinition
Surgical instrument assist arm system, manually-adjustedA manually-powered/-adjusted device assembly intended to be used to hold, maintain in a desired position, and enable positional adjustment of surgical and/or endoscopic instruments during an endoscopic examination/surgical procedure (i.e., during use). It typically consists of rigid or semi-rigid arms with joints, instrument holding and locking mechanisms, and a clamping mechanism for fixation to a stable object (e.g., the operating table) or is mounted on a mobile (on wheels) base.

Sterilization Methods

Method

Regulatory Flags

DUNS number
025033708
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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 DIBrandModelCatalogPublished
00850059853009Smeed TechnologiesST-MERK-EVAC-01A_ANZ2024-07-15
00850059853023Smeed TechnologiesST-MERK-TS_A042024-07-15
00850059853030Smeed TechnologiesST-MERK-02_04_AV2024-07-15
00850059853047Smeed TechnologiesST-MERK-01_0112024-07-15
00850059853054Smeed TechnologiesST-MERK-01_032024-07-15
00850059853061Smeed TechnologiesST-MERK-01A_01A2024-07-15
00850059853078Smeed TechnologiesST-MERK-AT-012024-07-15
00850059853085Smeed TechnologiesST-MERK-TXBAR-01_ANZ2024-07-15
00850059853092Smeed TechnologiesST-MERK-BR-01_ANZ2024-07-15
00850059853108Smeed TechnologiesST-MERK-TT-01_ANZ2024-07-15
00850059853115Smeed TechnologiesST-MERK-TS-360-01_ANZ2024-07-15
00850059853122Smeed TechnologiesST-MERK-3N1-01_ANZ2024-07-15
00850059853139Smeed TechnologiesST-MERK-ES_01_ANZ2024-07-15
00850059853146Smeed TechnologiesST-MERK-TS-FIXED-01_ANZ2024-07-15
00850059853153Smeed TechnologiesST-MERK-AV-01_MIL_20_ANZ2024-07-15
00850059853160Smeed TechnologiesST-MERK-TX-02B_ANZ2024-07-15
00850059853177Smeed TechnologiesST-MERK-AT-01_MIL_20_ANZ2024-07-15
00850059853184Smeed TechnologiesST-MERK-01_05U2024-07-15
00850059853191Smeed TechnologiesST-MERK-01_042024-07-15
00850059853207Smeed TechnologiesST-MERK-01_0122024-07-15

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
09420012405913Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-03-23
00810050863377ServiPlexLIFEPORT, LLCFOX2026-02-19
00810050863384ServiPlexLIFEPORT, LLCFOX2026-02-19
00761887005372PhotonicarePRYOR PRODUCTSFOX2026-02-16
00761887005389PhotonicarePRYOR PRODUCTSFOX2026-02-16
04061162071280CIM med GmbHCIM med GmbHFOX2026-02-01
04061162071310CIM med GmbHCIM med GmbHFOX2026-02-01
00810050863360Transition DeckLIFEPORT, LLCFOX2026-01-27
04061162100096CIM med GmbHCIM med GmbHFOX2026-01-14
00841027103233Pedigo Products, Inc.PEDIGO PRODUCTS, INC.FOX2026-01-08
00761887005358BaxterPRYOR PRODUCTSFOX2026-01-05
00761887005341PryorPRYOR PRODUCTSFOX2025-12-31
00041298995166HealthSmartD-M-S HOLDINGS, INC.FOX2025-12-29
06973456941064CORITONCORITON Instrument Co.,LtdFOX2025-12-29
06973456941071CORITONCORITON Instrument Co.,LtdFOX2025-12-29
04061162087212CIM med GmbHCIM med GmbHFOX2025-12-14
04260217220332AMTRION Infusion S-0725-F-2-SAmtrion GmbHFOX2025-12-10
00841027103226Pedigo Products, Inc.PEDIGO PRODUCTS, INC.FOX2025-11-29
06973456941033CORITONCORITON Instrument Co.,LtdFOX2025-11-27
00841027100324Pedigo Products, Inc. PEDIGO PRODUCTS, INC.FOX2025-11-26
00841027102472Pedigo Products, Inc. PEDIGO PRODUCTS, INC.FOX2025-11-26
00841027102489Pedigo Products, Inc. PEDIGO PRODUCTS, INC.FOX2025-11-26
00841027102496Pedigo Products, Inc. PEDIGO PRODUCTS, INC.FOX2025-11-26
00841027102502Pedigo Products, Inc. PEDIGO PRODUCTS, INC.FOX2025-11-26
00841027102519Pedigo Products, Inc. PEDIGO PRODUCTS, INC.FOX2025-11-26
00841027102526Pedigo Products, Inc. PEDIGO PRODUCTS, INC.FOX2025-11-26
00841027102533Pedigo Products, Inc. PEDIGO PRODUCTS, INC.FOX2025-11-26
00841027102540Pedigo Products, Inc. PEDIGO PRODUCTS, INC.FOX2025-11-26
00841027102557Pedigo Products, Inc. PEDIGO PRODUCTS, INC.FOX2025-11-26
00841027102564Pedigo Products, Inc. PEDIGO PRODUCTS, INC.FOX2025-11-26