FDA.reportPublic FDA data

Ponto

Primary DI
05712149009640
Brand
Ponto
Company
Oticon Medical AB
Model
M52321
Catalog number
M52321
Device description
Abutment extension, 1 mm
Published
2016-09-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXBHearing Aid, Bone Conduction
MAHHearing Aid, Bone Conduction, Implanted

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXBHearing Aid, Bone ConductionEar, Nose, Throat2
MAHHearing Aid, Bone Conduction, ImplantedEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05712149009640PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05712149009640057121490096405712149009640

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant/instrument adaptor, reusableA connecting device designed to join an implant to a surgical instrument or a surgical instrument to another instrument particularly to create an extension or to connect two devices where the interfaces of the devices are not compatible. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of sizes and lengths. This device can be used, e.g., during a percutaneous interspinous distraction procedure for the removal of a distraction sleeve. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height1Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-277-8014info@oticonmedical.com

Regulatory Flags#

DUNS number
554563994
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05712149026562Ponto2276862276862022-09-17
05712149026579Ponto2276872276872022-09-17
05712149026586Ponto2276882276882022-09-17
05712149026593Ponto2276892276892022-09-17
05712149026609Ponto2276902276902022-09-17
05712149026616Ponto2276912276912022-09-17
05712149026623Ponto2276922276922022-09-17
05712149026630Ponto2276932276932022-09-17
05712149026722Ponto2277022277022022-09-17
05712149026739Ponto2277032277032022-09-17
05712149026746Ponto2277042277042022-09-17
05712149026753Ponto2277052277052022-09-17
05712149026760Ponto2277062277062022-09-17
05712149026777Ponto2277072277072022-09-17
05712149026784Ponto2277082277082022-09-17
05712149026791Ponto2277092277092022-09-17
05712149027743Ponto Instant2846482846482026-05-21
05712149027453Ponto2676342676342023-08-21
05712149027460Ponto2676352676352023-08-21
05712149027477Ponto2676362676362023-08-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05712149027743Ponto InstantOticon Medical ABLXB2026-05-21
09120041056673contact forte AlphaBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056697contact forte AlphaBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056703contact forte AlphaBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056710contact forte AlphaBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056727contact forte AlphaBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056734contact forteBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056741contact forteBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056758contact forteBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056765contact forteBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056772contact forteBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056895HearbowBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041050145contact miniBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041050176contact miniBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041050190contact miniBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041050220contact miniBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041051852contact miniBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041051906contact miniBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041052149contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041052156contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041052163contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041052309contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041052316contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041052323contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041059575contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041059582contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041059599contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041059605contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041059612contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041059650contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17