FDA.report

MONO circlip

Primary DI
07640156471847
Brand
MONO circlip
Company
Thommen Medical AG
Model
2.03.170Q2
Published
2020-07-13
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
EJBHandle, Instrument, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EJBHandle, Instrument, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07640156471847PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07640156471847076401564718477640156471847

GMDN Terms

TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
481614829
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
07640182643355SPI®NEVO RC INICELL®, healing cap incl., PF 3.5, endosseous Ø 3.5 mm, L 8.0 mm4.23.0122024-02-14
07640182643362SPI®NEVO RC INICELL®, healing cap incl., PF 3.5, endosseous Ø 3.5 mm, L 9.5 mm4.23.0132024-02-14
07640182643379SPI®NEVO RC INICELL®, healing cap incl., PF 3.5, endosseous Ø 3.5 mm, L 11.0 mm4.23.0142024-02-14
07640182643386SPI®NEVO RC INICELL®, healing cap incl., PF 3.5, endosseous Ø 3.5 mm, L 12.5 mm4.23.0152024-02-14
07640182643393SPI®NEVO RC INICELL®, healing cap incl., PF 3.5, endosseous Ø 3.5 mm, L 14.0 mm4.23.0162024-02-14
07640182643409SPI®NEVO RC INICELL®, healing cap incl., PF 4.0, endosseous Ø 4.0 mm, L 6.5 mm4.23.0212024-02-14
07640182643416SPI®NEVO RC INICELL®, healing cap incl., PF 4.0, endosseous Ø 4.0 mm, L 8.0 mm4.23.0222024-02-14
07640182643423SPI®NEVO RC INICELL®, healing cap incl., PF 4.0, endosseous Ø 4.0 mm, L 9.5 mm4.23.0232024-02-14
07640182643430SPI®NEVO RC INICELL®, healing cap incl., PF 4.0, endosseous Ø 4.0 mm, L 11.0 mm4.23.0242024-02-14
07640182643447SPI®NEVO RC INICELL®, healing cap incl., PF 4.0, endosseous Ø 4.0 mm, L 12.5 mm4.23.0252024-02-14
07640182643454SPI®NEVO RC INICELL®, healing cap incl., PF 4.0, endosseous Ø 4.0 mm, L 14.0 mm4.23.0262024-02-14
07640182643461SPI®NEVO RC INICELL®, healing cap incl., PF 4.5, endosseous Ø 4.2 mm, L 6.5 mm4.23.0312024-02-14
07640182643478SPI®NEVO RC INICELL®, healing cap incl., PF 4.5, endosseous Ø 4.2 mm, L 8.0 mm4.23.0322024-02-14
07640182643485SPI®NEVO RC INICELL®, healing cap incl., PF 4.5, endosseous Ø 4.2 mm, L 9.5 mm4.23.0332024-02-14
07640182643492SPI®NEVO RC INICELL®, healing cap incl., PF 4.5, endosseous Ø 4.2 mm, L 11.0 mm4.23.0342024-02-14
07640182643508SPI®NEVO RC INICELL®, healing cap incl., PF 4.5, endosseous Ø 4.2 mm, L 12.5 mm4.23.0352024-02-14
07640182643515SPI®NEVO RC INICELL®, healing cap incl., PF 4.5, endosseous Ø 4.2 mm, L 14.0 mm4.23.0362024-02-14
07640182643522SPI®NEVO RC INICELL®, healing cap incl., PF 5.0, endosseous Ø 5.0 mm, L 6.5 mm4.23.0412024-02-14
07640182643539SPI®NEVO RC INICELL®, healing cap incl., PF 5.0, endosseous Ø 5.0 mm, L 8.0 mm4.23.0422024-02-14
07640182643546SPI®NEVO RC INICELL®, healing cap incl., PF 5.0, endosseous Ø 5.0 mm, L 9.5 mm4.23.0432024-02-14

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00841013120466Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EJB2026-01-06
30371347019668Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
30371347019675Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
30371347019682Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
30371347019699Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
00371347017724Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
00371347017748Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
00883205032164Slide PackerULTRADENT PRODUCTS, INC.EJB2025-08-21
00883205032157Slide PackerULTRADENT PRODUCTS, INC.EJB2025-08-19
08806343925183ever KITShinhung MST Co., Ltd.EJB2025-07-28
08806343925213TAPER KITShinhung MST Co., Ltd.EJB2025-07-28
08806343925220GUIDE KITShinhung MST Co., Ltd.EJB2025-07-28
08057639710567Specialist OrganizerMC BIO SRLEJB2025-06-23
08057639710574Tip with Indexable StopMC BIO SRLEJB2025-06-23
08057639710598Offset Tip SPMC BIO SRLEJB2025-06-23
08057639710604Long Tip SPMC BIO SRLEJB2025-06-23
08057639710628GBR MODULAR SETMC BIO SRLEJB2025-06-23
08057639712066Handle - Straight MDFMC BIO SRLEJB2025-06-23
08057639712073Handle - Straight - ErgalMC BIO SRLEJB2025-06-23
08057639712080Handle - Straight SP (TiN)MC BIO SRLEJB2025-06-23
08057639712097Handle - Asym. - ErgalMC BIO SRLEJB2025-06-23
08057639712103Handle - Asym. - SP (TiN)MC BIO SRLEJB2025-06-23
08057639712110Handle - Asym. - TitaniumMC BIO SRLEJB2025-06-23
08056992093119Starter SetMC BIO SRLEJB2025-06-20
08056992093126Basic SetMC BIO SRLEJB2025-06-20
08056992093133Advance SetMC BIO SRLEJB2025-06-20
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