NBH080120

GUDID 00840085270260

CORTICAL CANCELLOUS CANNULATED SCREW

HYHTE HOLDINGS, INC.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00840085270260
NIH Device Record Key2992cd75-96d6-4158-8f09-d114cfa38fba
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberNBH080120
Catalog NumberNBH080120
Company DUNS073029645
Company NameHYHTE HOLDINGS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM

Device Dimensions

Length120 Millimeter
Outer Diameter8 Millimeter
Length120 Millimeter
Outer Diameter8 Millimeter
Length120 Millimeter
Outer Diameter8 Millimeter
Length120 Millimeter
Outer Diameter8 Millimeter
Length120 Millimeter
Outer Diameter8 Millimeter
Length120 Millimeter
Outer Diameter8 Millimeter
Length120 Millimeter
Outer Diameter8 Millimeter
Length120 Millimeter
Outer Diameter8 Millimeter
Length120 Millimeter
Outer Diameter8 Millimeter
Length120 Millimeter
Outer Diameter8 Millimeter
Length120 Millimeter
Outer Diameter8 Millimeter
Length120 Millimeter
Outer Diameter8 Millimeter
Length120 Millimeter
Outer Diameter8 Millimeter
Length120 Millimeter
Outer Diameter8 Millimeter
Length120 Millimeter
Outer Diameter8 Millimeter
Length120 Millimeter
Outer Diameter8 Millimeter
Length120 Millimeter
Outer Diameter8 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840085270260 [Primary]

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840085270260]

Moist Heat or Steam Sterilization

[00840085270260]

Moist Heat or Steam Sterilization

[00840085270260]

Moist Heat or Steam Sterilization

[00840085270260]

Moist Heat or Steam Sterilization

[00840085270260]

Moist Heat or Steam Sterilization

[00840085270260]

Moist Heat or Steam Sterilization

[00840085270260]

Moist Heat or Steam Sterilization

[00840085270260]

Moist Heat or Steam Sterilization

[00840085270260]

Moist Heat or Steam Sterilization

[00840085270260]

Moist Heat or Steam Sterilization

[00840085270260]

Moist Heat or Steam Sterilization

[00840085270260]

Moist Heat or Steam Sterilization

[00840085270260]

Moist Heat or Steam Sterilization

[00840085270260]

Moist Heat or Steam Sterilization

[00840085270260]

Moist Heat or Steam Sterilization

[00840085270260]

Moist Heat or Steam Sterilization

[00840085270260]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-25
Device Publish Date2024-04-17

Devices Manufactured by HYHTE HOLDINGS, INC.

00840085254413 - NA2024-05-07 POLYAXIAL, TULIP
00840085254420 - NA2024-05-07 POLYAXIAL, HIGH TOP, TULIP
00840085254437 - NA2024-05-07 POLYAXIAL, EXTENDED TAB, TULIP
00840085254444 - NA2024-05-07 FAVORED ANGLE M/L, TULIP
00840085254451 - NA2024-05-07 FAVORED ANGLE M/L, HIGH TOP, TULIP
00840085254468 - NA2024-05-07 FAVORED ANGLE M/L, EXTENED TAB, TULIP
00840085254475 - NA2024-05-07 FAVORED ANGLE C/C, TULIP
00840085254482 - NA2024-05-07 FAVORED ANGLE C/C, HIGH TOP, TULIP
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