DENVER SPLINT

GUDID 00812185030105

SHIPPERT MEDICAL TECHNOLOGIES, INC

External nasal splint
Primary Device ID00812185030105
NIH Device Record Key1e83fdf0-4f71-45af-8316-054d40af5537
Commercial Distribution StatusIn Commercial Distribution
Brand NameDENVER SPLINT
Version Model Number10-4022-10NKP
Company DUNS051437143
Company NameSHIPPERT MEDICAL TECHNOLOGIES, 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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100812185030105 [Primary]

FDA Product Code

EPPSplint, Nasal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-05-23
Device Publish Date2018-09-20

On-Brand Devices [DENVER SPLINT]

0081218503032710-4021-05KP
0081218503031010-4022-05KS
0081218503030310-4022-05KP
0081218503029710-4022-05KM
0081218503028010-4022-05KL
0081218503027310-5500-10NKS
0081218503026610-5500-10NKP
0081218503025910-5500-10NKM
0081218503024210-5500-10NKL
0081218503023510-5000-10NKS
0081218503022810-5000-10NKP
0081218503021110-5000-10NKM
0081218503020410-5000-10NKL
0081218503018110-4032-10NKP
0081218503017410-4032-10NKM
0081218503016710-4032-10NKL
0081218503015010-4031-10NKS
0081218503014310-4031-10NKP
0081218503013600812185030136
0081218503012910-4031-10NKL
0081218503011210-4022-10NKS
0081218503010510-4022-10NKP
0081218503009910-4022-10NKM
0081218503008210-4022-10NKL
0081218503000610-4021-10NKS
008121850334273-H-SB-BB-4X30
0089339800282011-STARTERRHINO
0089339800299810-4021-10NKP
0089339800298110-3000-10NKS
0089339800297410-3000-10NKP
0089339800296710-3000-10NKM
0089339800295010-3000-10NKL
0089339800294310-2000-10NKS
0089339800293610-2000-10NKP
0089339800292910-2000-10NKM
0089339800291210-2000-10NKL
0089339800290510-1800-10NKS
0089339800289910-1800-10NKP
0089339800288210-1800-10NKM
0089339800287510-1800-10NKL
0089339800286810-1500-10NKS
0089339800285110-1500-10NKP
0089339800284410-1500-10NKM
0089339800283710-1500-10NKL
0089339800281310-5500-05KS
0089339800280610-5500-05KP
0089339800279010-5500-05KM
0089339800278310-5500-05KL
0089339800277610-5000-05KS
0089339800276910-5000-05KP

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.