N/A 405-697

GUDID 00846468041052

AWL

Pioneer Surgical Technology, Inc.

Bone awl Bone awl Bone awl Bone awl Bone awl Bone awl Bone awl Bone awl Bone awl Bone awl Bone awl Bone awl Bone awl Bone awl Bone awl Bone awl Bone awl Bone awl, reusable Bone awl, reusable Bone awl, reusable Bone awl, reusable Bone awl, reusable Bone awl, reusable Bone awl, reusable
Primary Device ID00846468041052
NIH Device Record Keyaedac5bb-4edf-445c-b5a2-0fad190b1d71
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model Number405-697
Catalog Number405-697
Company DUNS793384496
Company NamePioneer Surgical Technology, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100846468041052 [Primary]

FDA Product Code

HWJAWL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00846468041052]

Moist Heat or Steam Sterilization


[00846468041052]

Moist Heat or Steam Sterilization


[00846468041052]

Moist Heat or Steam Sterilization


[00846468041052]

Moist Heat or Steam Sterilization


[00846468041052]

Moist Heat or Steam Sterilization


[00846468041052]

Moist Heat or Steam Sterilization


[00846468041052]

Moist Heat or Steam Sterilization


[00846468041052]

Moist Heat or Steam Sterilization


[00846468041052]

Moist Heat or Steam Sterilization


[00846468041052]

Moist Heat or Steam Sterilization


[00846468041052]

Moist Heat or Steam Sterilization


[00846468041052]

Moist Heat or Steam Sterilization


[00846468041052]

Moist Heat or Steam Sterilization


[00846468041052]

Moist Heat or Steam Sterilization


[00846468041052]

Moist Heat or Steam Sterilization


[00846468041052]

Moist Heat or Steam Sterilization


[00846468041052]

Moist Heat or Steam Sterilization


[00846468041052]

Moist Heat or Steam Sterilization


[00846468041052]

Moist Heat or Steam Sterilization


[00846468041052]

Moist Heat or Steam Sterilization


[00846468041052]

Moist Heat or Steam Sterilization


[00846468041052]

Moist Heat or Steam Sterilization


[00846468041052]

Moist Heat or Steam Sterilization


[00846468041052]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-06
Device Publish Date2018-10-06

On-Brand Devices [N/A]

00846468060787Bipolar Forceps, Straight, 9.7", 0.4mm
00846468060527Bipolar Forceps, Bent, 9.7", Small
00846468060510Bipolar Forceps, Straight, 9.7", Small
00846468060466Bipolar Forceps, Bent, 9.7", 1.5mm Tip
00846468060435Bipolar Forceps, Bent, 9.7", 1.0mm Tip
00846468060404Bipolar Forceps, Bent, 9.7", 0.4mm Tip
00846468057572AUXILIARY CASE
00846468050542Bone Graft Delivery System
00846468049386Bipolar Forceps, Straight, 9.7", 1.5mm
00846468049287Bipolar Forceps, Straight, 9.7", Large
00846468049270Bipolar Forceps, Straight, 9.7", 1.0mm
00846468041052AWL
00846468041045HEX DRIVER, 3.5mm

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