FDA.reportPublic FDA data

Cohere

Primary DI
B14211000100010
Brand
Cohere
Company
VERTERA, INC.
Model
1100-01-0001
Device description
Inserter Retention
Published
2018-11-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B14211000100010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
078812764
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B14211000000010Cohere1100-00-00012018-11-09
B14211000000140Cohere1100-00-00142018-11-09
B14211000000160Cohere1100-00-00162018-11-09
B1422000001012080COALESCE2000-00-1012082018-11-09
B1422000001014080COALESCE2000-00-1014082018-11-09
B14220000128080COALESCE2000-01-28082018-11-09
B14220000128090COALESCE2000-01-28092018-11-09
B14220000128100COALESCE2000-01-28102018-11-09
B14220000128110COALESCE2000-01-28112018-11-09
B14220000128120COALESCE2000-01-28122018-11-09
B14220000128140COALESCE2000-01-28142018-11-09
B14220000132090COALESCE2000-01-32092018-11-09
B14220000132100COALESCE2000-01-32102018-11-09
B14220000132110COALESCE2000-01-32112018-11-09
B14220000132120COALESCE2000-01-32122018-11-09
B14220000132140COALESCE2000-01-32142018-11-09
B14220000132160COALESCE2000-01-32162018-11-09
B1422000000908000COALESCE2000-00-0908002017-11-09
B1422000000908080COALESCE2000-00-0908082017-11-09
B1422000000909000COALESCE2000-00-0909002017-11-09

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