FDA.reportPublic FDA data

Assisto® Arm-System

Primary DI
14049679077374
Brand
Assisto® Arm-System
Company
GEOMED Medizin-Technik GmbH & Co. KG
Model
CE 403-40-01
Device description
ASSISTO R400MM STAND 300MM W ENDO HOLDER 2,7-10MM
Published
2020-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14049679077374PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1404967907737414049679077374

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
316151174
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14049679077428Assisto® Arm-SystemCE 401-40-012021-07-19
14049679046165HERCULES® Wire CutterOL 603-18-012020-11-17
14049679046202HERCULES® Wire CutterOL 605-23-012020-11-17
14049679046288HERCULES® Wire CutterOL 620-28-012020-11-17
14049679095613HERCULES® Wire CutterOL 610-23-012020-11-17
14049679077831Assisto® Arm-SystemCI 422-00-092019-04-29
14049679076681ASSISTO® Arm-SystemCA 235-30-01CA 235-30-012017-02-23
14049679076735ASSISTO® Arm-SystemCA 301-20-01CA 301-20-012016-12-20
14049679076803ASSISTO® Arm-SystemCA 305-22-01CA 305-22-012016-12-19
14049679077787ASSISTO® Arm-SystemCI 404-01-012018-05-22
14049679078425Assisto® Arm-SystemCI 415-02-012019-03-01
14049679079583ASSISTO® Arm-SystemCI 310-50-012019-03-01
14049679092957ASSISTO® Arm-SystemCA 450-40-012018-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776423605MillenniumAvalign Technologies, Inc.GCJ2026-08-07
00190776423650MillenniumAvalign Technologies, Inc.GCJ2026-08-07
00190776423667MillenniumAvalign Technologies, Inc.GCJ2026-08-07
00190776424510MillenniumAvalign Technologies, Inc.GCJ2026-08-07
00190776422745MillenniumAvalign Technologies, Inc.GCJ2026-08-03
00190776422752MillenniumAvalign Technologies, Inc.GCJ2026-08-03
04026704934812TELEFLEXTELEFLEX INCORPORATEDGCJ2026-08-03
B382SD4131490Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD4162910Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD49245120Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD55670280Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56325330Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56400150Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56534210Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD567910130Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56914330Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
00190776421960MillenniumAvalign Technologies, Inc.GCJ2026-07-31
00190776422325MillenniumAvalign Technologies, Inc.GCJ2026-07-31
00888867498105Arthrex®ARTHREX, INC.GCJ2026-07-31
14026704921741TELEFLEXTELEFLEX INCORPORATEDGCJ2026-07-31
B382SD13768130Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD13798130Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD14678780Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD15378970Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD15458990Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD161090Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD169920Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD30109760Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
00198506092183ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
00198506092640ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29