ARCH BAR

GUDID 00888118063090

ERICH

KLS-Martin L.P.

Craniofacial bone wire/bar
Primary Device ID00888118063090
NIH Device Record Keycfc94474-05a6-4e0a-8b47-175aee769ebf
Commercial Distribution StatusIn Commercial Distribution
Brand NameARCH BAR
Version Model Number38-690-00-07
Company DUNS826499238
Company NameKLS-Martin L.P.
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

Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100888118063090 [Primary]

FDA Product Code

DYXLOCK, WIRE, AND LIGATURE, INTRAORAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00888118063090]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-08-22
Device Publish Date2016-09-20

Devices Manufactured by KLS-Martin L.P.

00888118143396 - LEVEL ONE CMF, STERILE2024-07-29 PLATE, ORTHOG, BSSO, LADDER, CVD, 4 MM BRG, 2.0 MM SCREW, TI-6AL-4V
00888118143419 - LEVEL ONE CMF, STERILE2024-07-29 PLATE, ORTHOG, BSSO, LADDER, CVD, 8 MM BRG, 2.0 MM SCREW, TI-6AL-4V
00888118143433 - LEVEL ONE CMF, STERILE2024-07-29 PLATE, ORTHOG, BSSO, LADDER, CVD, 11 MM BRG, 2.0 MM SCREW, TI-6AL-4V
00888118143235 - LEVEL ONE NEURO2024-07-02 MESH, SPECIALTY, ULTRAONE, W/BORDER, NEURO SCREW, CP TITANIUM
00888118143242 - LEVEL ONE NEURO2024-07-02 MESH, SPECIALTY, ULTRAONE, W/BORDER, NEURO SCREW, CP TITANIUM
00888118143259 - RULER2024-05-29
00888118141996 - L12024-02-29
00888118142092 - L1 STERNAL2024-02-29

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