FDA.reportPublic FDA data

NA

Primary DI
00840085237119
Brand
NA
Company
HYHTE HOLDINGS, INC.
Model
LZE020000
Catalog number
LZE020000
Device description
NAIL REMOVER
Published
2021-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840085237119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840085237119008400852371198400852371190840085237119

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

Contacts#

Phone, Email table
PhoneEmail
7608148047PARKER@ASTURAMEDICAL.COM

Regulatory Flags#

DUNS number
073029645
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
00840085271861NAAZA083000AZA0830002025-02-26
00840085271878NAAZA084000AZA0840002025-02-26
00840085271885NAAZA084001AZA0840012025-02-26
00840085271892NAAZA085000AZA0850002025-02-26
00840085271908NAAZA085001AZA0850012025-02-26
00840085271915NAAZA086000AZA0860002025-02-26
00840085271922NAAZA088035AZA0880352025-02-26
00840085271939NAAZA088040AZA0880402025-02-26
00840085271946NAAZA088045AZA0880452025-02-26
00840085271953NAAZA088050AZA0880502025-02-26
00840085271960NAAZA088055AZA0880552025-02-26
00840085271977NAAZA088060AZA0880602025-02-26
00840085271984NAAZA088065AZA0880652025-02-26
00840085271991NAAZA088070AZA0880702025-02-26
00840085272004NAAZA088075AZA0880752025-02-26
00840085272011NAAZA088080AZA0880802025-02-26
00840085272028NAAZA088085AZA0880852025-02-26
00840085272035NAAZA088090AZA0880902025-02-26
00840085272042NAAZA088095AZA0880952025-02-26
00840085272066NAAZA091000AZA0910002025-02-26

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810056992804aprevoCarlsmed, Inc.OVE2026-03-17
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00810056992958aprevoCarlsmed, Inc.OVE2026-03-17
00763000880422Endoskeleton™ TCS Interbody SystemMEDTRONIC SOFAMOR DANEK, INC.OVE2026-03-02
10195860030407E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
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10195860030469E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030476E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030483E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030490E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030513E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030520E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030544E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030629E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030636E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030643E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030650E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030667E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030681E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030698E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030711E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030735E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030759E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030773E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030797E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030865E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030872E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030902E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030933E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20