FDA.report

ANKYLOS®

Primary DI
07392532219702
Brand
ANKYLOS®
Company
Dentsply Implants Manufacturing GmbH
Model
31036540
Catalog number
31036540
Device description
Surgical Kit Tray ABC empty
Published
2022-07-14
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
NDPAccessories, implant, dental, endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07392532219702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07392532219702073925322197027392532219702

GMDN Terms

TermDefinition
Surgical instrument/implant rackA device designed as a small case, typically with a hinged lid that can be closed to protect the contents (i.e., surgical instruments and/or implantable devices such as plates or screws), and an integral rest(s) with grooves or notches in the upper edge so that the contents can be securely placed, protected, and organized. The lid or rest may be set at an angle to facilitate instrument/implant access during surgical procedures or sterilization. The device is typically be made of stainless steel or a suitable plastic material so that it can be sterilized. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
344038836
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
07392532207082SIMPLANT®54500173545001732026-03-12
07392532236013SIMPLANT®54500105545001052026-03-10
07392532207150SIMPLANT®54500175545001752026-03-10
07392532207112SIMPLANT®54500179545001792026-03-10
07392532207181SIMPLANT®54500180545001802026-03-10
07392532207068SIMPLANT®54500185545001852026-03-10
07392532207013SIMPLANT®54500187545001872026-03-10
07392532207266SIMPLANT®54500194545001942026-03-10
07392532236051SIMPLANT®54500197545001972026-03-10
07392532236020SIMPLANT®54500214545002142026-03-10
07392532281266ATLANTIS®68020074680200742025-12-18
07392532281280ATLANTIS®68020076680200762025-12-18
07392532215278ANKYLOS®31021100310211002020-11-18
07392532215285ANKYLOS®31021110310211102020-11-18
07392532215339ANKYLOS®31021160310211602020-11-18
07392532215353ANKYLOS®31021180310211802020-11-18
07392532215865ANKYLOS®31021630310216302020-11-18
07392532215896ANKYLOS®31021647310216472020-11-18
07392532215988ANKYLOS®31021660310216602020-11-18
07392532216572ANKYLOS®31022540310225402020-11-18

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