Quala Chromic Gut Suture P00635

GUDID D023P006351

Quala gut chromic 4/0 27 C-6 suture absorbable

NATIONAL DISTRIBUTION & CONTRACTING, INC.

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Primary Device IDD023P006351
NIH Device Record Key0f15839a-3602-4779-9ba4-7af70c85fa06
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuala Chromic Gut Suture
Version Model NumberP00635
Catalog NumberP00635
Company DUNS009831413
Company NameNATIONAL DISTRIBUTION & CONTRACTING, 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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone6153663225
Emailcompliance@ndc-inc.com
Phone6153663225
Emailcompliance@ndc-inc.com
Phone6153663225
Emailcompliance@ndc-inc.com
Phone6153663225
Emailcompliance@ndc-inc.com
Phone6153663225
Emailcompliance@ndc-inc.com
Phone6153663225
Emailcompliance@ndc-inc.com
Phone6153663225
Emailcompliance@ndc-inc.com
Phone6153663225
Emailcompliance@ndc-inc.com
Phone6153663225
Emailcompliance@ndc-inc.com
Phone6153663225
Emailcompliance@ndc-inc.com
Phone6153663225
Emailcompliance@ndc-inc.com
Phone6153663225
Emailcompliance@ndc-inc.com
Phone6153663225
Emailcompliance@ndc-inc.com
Phone6153663225
Emailcompliance@ndc-inc.com
Phone6153663225
Emailcompliance@ndc-inc.com
Phone6153663225
Emailcompliance@ndc-inc.com
Phone6153663225
Emailcompliance@ndc-inc.com
Phone6153663225
Emailcompliance@ndc-inc.com
Phone6153663225
Emailcompliance@ndc-inc.com
Phone6153663225
Emailcompliance@ndc-inc.com
Phone6153663225
Emailcompliance@ndc-inc.com
Phone6153663225
Emailcompliance@ndc-inc.com
Phone6153663225
Emailcompliance@ndc-inc.com
Phone6153663225
Emailcompliance@ndc-inc.com
Phone6153663225
Emailcompliance@ndc-inc.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD023P006350 [Primary]
HIBCCD023P006351 [Package]
Contains: D023P006350
Package: [12 Units]

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 Number3
Public Version Date2021-02-05
Device Publish Date2017-02-13

On-Brand Devices [Quala Chromic Gut Suture]

D023P006351Quala gut chromic 4/0 27 C-6 suture absorbable
D023P005581Quala chromic gut 4/0 18 C-6 absorbable suture

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