Clamp - Bar To Bar

Primary DI
00850062461673
Brand
Clamp - Bar To Bar
Company
Medshape, Inc.
Model
DNE-9000-BTB
Published
2024-05-31
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
true

Product Codes#

Code, Name table
CodeName
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850062461673PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850062461673008500624616738500624616730850062461673

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbableA non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
601306413
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
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M97015000009200Eclipse1500-00-09202017-02-16
M97029002402500DynaNail Mini2900-24-02502023-06-21
M97015000400000Eclipse1500-04-00002023-01-10
M97022001100010DynaNail2200-11-00012023-05-05
M97022002900000DynaNail2200-29-00002016-06-17
M97022010900400DynaNail2201-09-00402023-06-22
M9702300010500Eclipse2300-01-0502023-01-10
M9702300010550Eclipse2300-01-0552023-01-10
M9702300010600Eclipse2300-01-0602023-01-10
M9702300010700Eclipse2300-01-0702023-01-10
M9702300010800Eclipse2300-01-0802023-01-10
M9702300010900Eclipse2300-01-0902023-01-10
M97029000103000DynaNail Mini 2900-01-03002023-06-12
M97029000700000DynaNail Mini2900-07-00002019-04-09
M9703000010000DynaClip3000-01-0002018-11-26
M97030000400000DynaClip Forte3000-04-0002020-05-14
M9703000112220200DynaClip Quattro3000-11-2220202022-09-16
M9703000130000DynaClip Quattro3000-13-0002023-03-15
M9701000032250Morphix XT1000-03-2252017-05-19
M9701000032350Morphix XT1000-03-2352017-05-19

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Primary DI, Brand, Company table
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