NBV075080

GUDID 00840085278563

S2AI, CANNULATED, FENESTRATED, ASTURABOND FINISH

Astura Medical

Surgical tamp, reusable
Primary Device ID00840085278563
NIH Device Record Keybc4d3ac5-ac11-4ede-a66f-f43742465922
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberNBV075080
Catalog NumberNBV075080
Company DUNS073029645
Company NameAstura Medical
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

Device Dimensions

Length70 Millimeter
Width7.5 Millimeter
Length70 Millimeter
Width7.5 Millimeter
Length70 Millimeter
Width7.5 Millimeter
Length70 Millimeter
Width7.5 Millimeter
Length70 Millimeter
Width7.5 Millimeter
Length70 Millimeter
Width7.5 Millimeter
Length70 Millimeter
Width7.5 Millimeter
Length70 Millimeter
Width7.5 Millimeter
Length70 Millimeter
Width7.5 Millimeter
Length70 Millimeter
Width7.5 Millimeter
Length70 Millimeter
Width7.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840085278563 [Primary]

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840085278563]

Moist Heat or Steam Sterilization


[00840085278563]

Moist Heat or Steam Sterilization


[00840085278563]

Moist Heat or Steam Sterilization


[00840085278563]

Moist Heat or Steam Sterilization


[00840085278563]

Moist Heat or Steam Sterilization


[00840085278563]

Moist Heat or Steam Sterilization


[00840085278563]

Moist Heat or Steam Sterilization


[00840085278563]

Moist Heat or Steam Sterilization


[00840085278563]

Moist Heat or Steam Sterilization


[00840085278563]

Moist Heat or Steam Sterilization


[00840085278563]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-02
Device Publish Date2025-11-24

Devices Manufactured by Astura Medical

00840085233500 - DOLOMITE2025-12-10 STRAIGHT TAMP
00840085233517 - DOLOMITE2025-12-10 ROTATION TAMP
00840085233524 - DOLOMITE2025-12-10 LOCK DRIVER
00840085235078 - DOLOMITE2025-12-10 SCREWDRIVER, T10A
00840085235085 - DOLOMITE2025-12-10 SCREW REMOVER, T10A
00840085236938 - DOLOMITE2025-12-10 FIXED ANGLE DRIVER
00840085236990 - DOLOMITE2025-12-10 FIXED ANGLE LOCK DRIVER
00840085242274 - DOLOMITE2025-12-10 FIXED ANGLE DRIVER BIT SOCKET

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