FDA.reportPublic FDA data

NA

Primary DI
04250869634953
Brand
NA
Company
Biedermann Motech GmbH & Co. KG
Model
207-060-0116
Catalog number
207-060-0116
Device description
DELTA XS Retractor Blade 65mm, curved, medial / lateral
Published
2018-11-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GADRETRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250869634953PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250869634953042508696349534250869634953

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
320249162
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04255772613071NA207-060-0138207-060-01382025-08-08
04255772613088NA207-060-0137207-060-01372025-08-08
04250869654180NA108-004-0004108-004-00042020-08-14
04250869602907NA107-004-0001107-004-00012017-01-10
04250869607469NA109-015-0828109-015-08282017-06-20
04250869607629NA109-031-0728109-031-07282017-06-20
04250869607636NA109-015-0928109-015-09282017-06-20
04250869607643NA109-015-1028109-015-10282017-06-20
04250869607650NA109-015-1128109-015-11282017-06-20
04250869607667NA109-015-1228109-015-12282017-06-20
04250869607674NA109-015-1328109-015-13282017-06-20
04250869607681NA109-031-0732109-031-07322017-06-20
04250869607698NA109-015-0832109-015-08322017-06-20
04250869607704NA109-015-0932109-015-09322017-06-20
04250869607711NA109-015-1032109-015-10322017-06-20
04250869607728NA109-015-1132109-015-11322017-06-20
04250869607735NA109-015-1232109-015-12322017-06-20
04250869607742NA109-015-1332109-015-13322017-06-20
04250869607759NA109-015-1432109-015-14322017-06-20
04250869607766NA109-015-1532109-015-15322017-06-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810118343124StieberAutomated Medical Products Corp.GAD2026-05-28
00810118343131StieberAutomated Medical Products Corp.GAD2026-05-28
00810118343148StieberAutomated Medical Products Corp.GAD2026-05-28
00810118343155StieberAutomated Medical Products Corp.GAD2026-05-28
00810118343162StieberAutomated Medical Products Corp.GAD2026-05-28
00810118343179StieberAutomated Medical Products Corp.GAD2026-05-28
00841536147810ThompsonThompson Surgical Instruments, Inc.GAD2026-05-27
G453BH72800PEAK MEDICALPeak Medical Distribution Inc.GAD2026-03-30
07640332476321SCARLET AL-T INSTRUMENTATIONSpineArt SAGAD2025-11-10
07640375234681PERLA ® TL MISSpineArt SAGAD2025-11-10
07640375234698PERLA ® TL MISSpineArt SAGAD2025-11-10
07640375234704PERLA ® TL MISSpineArt SAGAD2025-11-10
07640375234711PERLA ® TL MISSpineArt SAGAD2025-11-10
08904332600681MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-11-04
08904332600698MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-11-04
08904332600704MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-11-04
08904332600711MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-11-04
G453TR251320PEAK MEDICALPeak Medical Distribution Inc.GAD2025-10-15
08800071700487Tiger ViewKims Med Co.,Ltd.GAD2025-10-15
08800071017240SignexOSTEONIC CO.,Ltd.GAD2025-06-24
08904332600582MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-05-13
08904332600599MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-05-13
08904332600605MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-05-13
08904332600612MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-05-13
08904332600629MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-05-13
08904332600476MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-03-10
08904332600483MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-03-10
08904332600490MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-03-10
08800071700357Tiger ViewKims Med Co.,Ltd.GAD2025-02-10
08800071700371Tiger View Kims Med Co.,Ltd.GAD2025-02-10