DENVER SPLINT

GUDID 10385640048955

SUMMIT MEDICAL, INC.

External nasal splint External nasal splint External nasal splint External nasal splint External nasal splint External nasal splint External nasal splint External nasal splint External nasal splint External nasal splint External nasal splint External nasal splint External nasal splint External nasal splint External nasal splint External nasal splint
Primary Device ID10385640048955
NIH Device Record Key011d456f-f1b2-4f1c-9934-7e8ba0d28264
Commercial Distribution StatusIn Commercial Distribution
Brand NameDENVER SPLINT
Version Model Number10-4021-10NKL
Company DUNS965484699
Company NameSUMMIT MEDICAL, 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
GS100385640048958 [Primary]
GS110385640048955 [Package]
Contains: 00385640048958
Package: BOX [10 Units]
In Commercial Distribution

FDA Product Code

EPPSplint, Nasal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-08
Device Publish Date2021-03-31

On-Brand Devices [DENVER SPLINT]

1038564004926610-4022-10NKL
1038564004923510-4022-10NKM
1038564004893110-4021-10NKP
1038564004891710-4022-05KL
1038564004890010-4022-05KS
1038564004889410-4022-05KP
1038564004922810-4031-10NKL
1038564004921110-4031-10NKS
1038564004920410-4031-10NKP
1038564004919810-4031-10NKM
1038564004917410-4032-05KL
1038564004914310-4032-05KM
1038564004894810-4021-10NKS
1038564004888710-4022-05KM
1038564005296910-1500-05KS
1038564005294510-1500-05KP
1038564005293810-1500-05KM
1038564005292110-1500-05KL
1038564004899310-4021-05KL
1038564004898610-4021-05KS
1038564004897910-4021-05KP
1038564004896210-4021-05KM
1038564005300310-1500-10NKS
1038564005299010-1500-10NKP
1038564005298310-1500-10NKM
1038564005297610-1500-10NKL
1038564004895510-4021-10NKL
1038564004892410-4021-10NKM

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