Burkhart 3-0 Plain Gut Suture 27", C-7 Needle

GUDID 10854212006056

BURKHART DENTAL SUPPLY CO., THE

Catgut suture, plain
Primary Device ID10854212006056
NIH Device Record Key70eccdb3-4695-43b6-89f4-d037150e771d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBurkhart 3-0 Plain Gut Suture 27", C-7 Needle
Version Model Number72720764
Company DUNS027532357
Company NameBURKHART DENTAL SUPPLY CO., THE
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100854212006059 [Primary]
GS110854212006056 [Package]
Contains: 00854212006059
Package: [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GALSuture, Absorbable, Natural

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-03-03

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