IPS

GUDID 00888118120571

KLS-Martin L.P.

Custom-made organ/bone anatomy model
Primary Device ID00888118120571
NIH Device Record Keyf4972bba-ff4b-4be4-a00d-e8c126865db0
Commercial Distribution StatusIn Commercial Distribution
Brand NameIPS
Version Model Number60-001-32-09
Company DUNS826499238
Company NameKLS-Martin L.P.
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 Numbertrue
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
Email[email protected]

Device Identifiers

Device Issuing AgencyDevice ID
GS100888118120571 [Primary]

FDA Product Code

HWTTEMPLATE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00888118120571]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-27
Device Publish Date2018-12-28

On-Brand Devices [IPS]

1088811811734960-500-03-09
1088811811733260-500-02-09
1088811811732560-500-01-09
1088811809782560-002-10-09
1088811809781860-002-09-09
1088811809780160-002-08-09
1088811809779560-002-07-09
1088811809778860-002-06-09
1088811809777160-002-05-09
00888118117366CUTTING GUIDE, RECON, STANDARD, 00162
00888118117359CUTTING GUIDE, RECON, BONE GRAFT, 00161
0088811811592860-001-52-09
0088811811590460-001-50-09
0088811811589860-001-49-09
0088811811584360-001-44-09
0088811811583660-001-43-09
0088811811582960-001-42-09
0088811811581260-001-41-09
0088811811579960-001-12-09
0088811811578260-001-11-09
0088811811577560-001-10-09
0088811811576860-001-09-09
0088811811575160-001-08-09
0088811811574460-001-07-09
0088811811573760-001-06-09
0088811811572060-001-05-09
0088811811571360-001-04-09
0088811811570660-001-03-09
0088811811569060-001-02-09
0088811811568360-001-01-09
0088811811567660-001-00-09
0088811812177660-500-21-09
00888118120793IMPLANT, MIDFACE, 00198, TI-6AL-4V
00888118120786IMPLANT, MANDIBLE, CRIB MESH, 00195, TI-6AL-4V
00888118120595IMPLANT, MIDFACE, 00194, PEEK
00888118120090CUTTING GUIDE, RECON, CUTTING SLOT
00888118120007MARKING GUIDE, RECON/DIST, EXTRA, LARGE
00888118119995MARKING GUIDE, RECON/DIST, EXTRA, SMALL
00888118119988MARKING GUIDE, W/PLANNING, RECON/DIST
00888118119971CUTTING GUIDE, RECON, EXTRA, LARGE
00888118119964CUTTING GUIDE, RECON, EXTRA, SMALL
00888118119957CUTTING GUIDE, W/PLANNING, RECON
00888118119940MARKING GUIDE, ORTHOG/MAND, 00197
00888118119933MARKING GUIDE, ORTHOG/MAX, 00196
00888118119926CUTTING GUIDE, ORTHOG, COMPLEX, 00163
00888118119919CUTTING GUIDE, W/PLANNING, RECON, COMPLEX, 00160
00888118119902MARKING GUIDE, RECON, BONE GRAFT, 00012
00888118106353PEEK, LARGE, PEEK
00888118106018IPS, PEEK, PEEK
00888118105653PEEK, PEEK

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