FDA.report

MONDEAL

Primary DI
04050435067648
Brand
MONDEAL
Company
MONDEAL Medical Systems GmbH
Model
27-05720
Catalog number
27-05720
Device description
Tap 3.5 x 124 mm WL 14 mm AO cannulated 2 x green for 3.5 mm screws
Published
2017-06-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04050435067648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04050435067648040504350676484050435067648

GMDN Terms

TermDefinition
Bone tap, reusableA metal surgical instrument designed for cutting internal threads into bone so that the threads facilitate the insertion of bone screws. The screws anchor bone fragments, fixtures and/or other devices to the bone. It is made of high-grade stainless steel and has a helical thread intersected with longitudinal cutting grooves forming the cutting edges at its distal end and may be cannulated. The proximal end typically terminates in a square to which a tapping instrument or extension can be attached. It will typically be manually rotated in order to create a best possible thread. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+497463993070mail@mondeal.de
+1904-641-7746KLS-UDI-Info@klsmartin.com

Regulatory Flags

DUNS number
312546955
Device count
1
DM exempt
false
Premarket exempt
false
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
true
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04050435135255MONDEAL27-0650027-065002021-07-07
04050435135262MONDEAL27-0650127-065012021-07-07
04050435135279MONDEAL27-0650227-065022021-07-07
04050435135286MONDEAL27-0650727-065072021-07-07
04050435135293MONDEAL27-0650827-065082021-07-07
04050435135309MONDEAL27-0803427-080342021-07-07
04050435135316MONDEAL27-0803627-080362021-07-07
04050435040511MONDEAL27-0374927-037492020-10-21
04050435040528MONDEAL27-0377327-037732020-10-21
04050435040535MONDEAL27-0379827-037982020-10-21
04050435069185MONDEAL27-0373227-037322020-10-21
04050435069192MONDEAL27-0376427-037642020-10-21
04050435069208MONDEAL27-0378527-037852020-10-21
04050435113758MONDEAL26-5071626-507162020-10-21
04050435113772MONDEAL26-5072026-507202020-10-21
04050435113789MONDEAL26-5072226-507222020-10-21
04050435114564MONDEAL26-5071426-507142020-10-21
04050435114939MONDEAL26-5072426-507242020-10-21
04050435118630MONDEAL26-5072626-507262020-10-21
04050435118647MONDEAL26-5072826-507282020-10-21

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