FDA.reportPublic FDA data

DIRECTscan™ Adapter Kit - Empty

Primary DI
10841307135197
Brand
DIRECTscan™ Adapter Kit - Empty
Company
IMPLANT DIRECT SYBRON MANUFACTURING LLC
Model
DSK-E
Catalog number
DSK-E
Published
2025-04-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841307135197PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084130713519710841307135197

GMDN Terms#

Term, Definition table
TermDefinition
Medical device integration rackA device that is designed as an instrument rack (maybe cabinet-like with closed sides) and is used for mounting and organizing several medical devices that are intended to interact (integrated instrumentation). It is typically mobile (on wheels) and has built-in grounded outlets, pull-out shelves, working surfaces, and may even be equipped with a built-in transformer. This device, when supplied with the instrumentation fitted, will become a system and will require product identification of the whole as a system.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-649-6425customerservice@implantdirect.com

Regulatory Flags#

DUNS number
868856969
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841307135883Legacy™ DIRECTarch™ 3.0 MUA Replacement ScrewDA1000-20S-AUDA1000-20S-AU2026-10-20
10841307135890Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 1.0mmL CollarDA8730-61S-AUDA8730-61S-AU2026-10-20
10841307135906Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 2.0mmL CollarDA8730-62S-AUDA8730-62S-AU2026-10-20
10841307135913Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 3.0mmL CollarDA8730-63S-AUDA8730-63S-AU2026-10-20
10841307135920Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 4.0mmL CollarDA8730-64S-AUDA8730-64S-AU2026-10-20
10841307135937Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 5.0mmL CollarDA8730-65S-AUDA8730-65S-AU2026-10-20
10841307135944Legacy™ DIRECTarch™ 3.0mmD Platform 17° MUA 1.0mmL CollarDA8730-61-17S-AUDA8730-61-17S-AU2026-10-20
10841307135951Legacy™ DIRECTarch™ 3.0mmD Platform 17° MUA 2.0mmL CollarDA8730-62-17S-AUDA8730-62-17S-AU2026-10-20
10841307135968Legacy™ DIRECTarch™ 3.0mmD Platform 30° MUA 1.0mmL CollarDA8730-61-30S-AUDA8730-61-30S-AU2026-10-20
10841307135975Legacy™ DIRECTarch™ 3.0mmD Platform 30° MUA 2.0mmL CollarDA8730-62-30S-AUDA8730-62-30S-AU2026-10-20
10841307135982Legacy™ DIRECTarch™ 3.5 MUA Replacement ScrewDA1000-01SG-AUDA1000-01SG-AU2026-10-20
10841307135999Legacy™ DIRECTarch™ 3.5mmD Platform Straight MUA 1.0mmL CollarDA1000-01SG-AUDA8735-61S-AU2026-10-20
10841307136002Legacy™ DIRECTarch™ 3.5mmD Platform Straight MUA 2.0mmL CollarDA8735-62S-AUDA8735-62S-AU2026-10-20
10841307136019Legacy™ DIRECTarch™ 3.5mmD Platform Straight MUA 3.0mmL CollarDA8735-63S-AUDA8735-63S-AU2026-10-20
10841307136026Legacy™ DIRECTarch™ 3.5mmD Platform Straight MUA 4.0mmL CollarDA8735-64S-AUDA8735-64S-AU2026-10-20
10841307136033Legacy™ DIRECTarch™ 3.5mmD Platform Straight MUA 5.0mmL CollarDA8735-65S-AUDA8735-65S-AU2026-10-20
10841307136040Legacy™ DIRECTarch™ 3.5mmD Platform 17° MUA 1.0mmL CollarDA8735-61-17S-AUDA8735-61-17S-AU2026-10-20
10841307136057Legacy™ DIRECTarch™ 3.5mmD Platform 17° MUA 2.0mmL CollarDA8735-62-17S-AUDA8735-62-17S-AU2026-10-20
10841307136064Legacy™ DIRECTarch™ 3.5mmD Platform 30° MUA 1.0mmL CollarDA8735-61-30S-AUDA8735-61-30S-AU2026-10-20
10841307136071Legacy™ DIRECTarch™ 3.5mmD Platform 30° MUA 2.0mmL CollarDA8735-62-30S-AUDA8735-62-30S-AU2026-10-20