NBH075090

GUDID 00840085270086

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 ID00840085270086
NIH Device Record Key18c8fab5-e993-49d4-b7e7-3cb0c45c539f
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberNBH075090
Catalog NumberNBH075090
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

Length90 Millimeter
Outer Diameter7.5 Millimeter
Length90 Millimeter
Outer Diameter7.5 Millimeter
Length90 Millimeter
Outer Diameter7.5 Millimeter
Length90 Millimeter
Outer Diameter7.5 Millimeter
Length90 Millimeter
Outer Diameter7.5 Millimeter
Length90 Millimeter
Outer Diameter7.5 Millimeter
Length90 Millimeter
Outer Diameter7.5 Millimeter
Length90 Millimeter
Outer Diameter7.5 Millimeter
Length90 Millimeter
Outer Diameter7.5 Millimeter
Length90 Millimeter
Outer Diameter7.5 Millimeter
Length90 Millimeter
Outer Diameter7.5 Millimeter
Length90 Millimeter
Outer Diameter7.5 Millimeter
Length90 Millimeter
Outer Diameter7.5 Millimeter
Length90 Millimeter
Outer Diameter7.5 Millimeter
Length90 Millimeter
Outer Diameter7.5 Millimeter
Length90 Millimeter
Outer Diameter7.5 Millimeter
Length90 Millimeter
Outer Diameter7.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840085270086 [Primary]

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840085270086]

Moist Heat or Steam Sterilization

[00840085270086]

Moist Heat or Steam Sterilization

[00840085270086]

Moist Heat or Steam Sterilization

[00840085270086]

Moist Heat or Steam Sterilization

[00840085270086]

Moist Heat or Steam Sterilization

[00840085270086]

Moist Heat or Steam Sterilization

[00840085270086]

Moist Heat or Steam Sterilization

[00840085270086]

Moist Heat or Steam Sterilization

[00840085270086]

Moist Heat or Steam Sterilization

[00840085270086]

Moist Heat or Steam Sterilization

[00840085270086]

Moist Heat or Steam Sterilization

[00840085270086]

Moist Heat or Steam Sterilization

[00840085270086]

Moist Heat or Steam Sterilization

[00840085270086]

Moist Heat or Steam Sterilization

[00840085270086]

Moist Heat or Steam Sterilization

[00840085270086]

Moist Heat or Steam Sterilization

[00840085270086]

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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