E.M Adams co, inc.

GUDID 50840200302871

SUTURE REMOVAL

E.M. ADAMS, INC.

Suture removal kit Suture removal kit Suture removal kit Suture removal kit Suture removal kit Suture removal kit Suture removal kit Suture removal kit Suture removal kit Suture removal kit Suture removal kit Suture removal kit Suture removal kit Suture removal kit Suture removal kit Suture removal kit
Primary Device ID50840200302871
NIH Device Record Key1e1ddb77-d48f-451d-879e-680bd9fa7a0a
Commercial Distribution StatusIn Commercial Distribution
Brand NameE.M Adams co, inc.
Version Model Number14-70845-1
Company DUNS001403807
Company NameE.M. ADAMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(772)461-0532
EmailEMADAMS@EMADAMSCO.COM
Phone+1(772)461-0532
EmailEMADAMS@EMADAMSCO.COM
Phone+1(772)461-0532
EmailEMADAMS@EMADAMSCO.COM
Phone+1(772)461-0532
EmailEMADAMS@EMADAMSCO.COM
Phone+1(772)461-0532
EmailEMADAMS@EMADAMSCO.COM
Phone+1(772)461-0532
EmailEMADAMS@EMADAMSCO.COM
Phone+1(772)461-0532
EmailEMADAMS@EMADAMSCO.COM
Phone+1(772)461-0532
EmailEMADAMS@EMADAMSCO.COM
Phone+1(772)461-0532
EmailEMADAMS@EMADAMSCO.COM
Phone+1(772)461-0532
EmailEMADAMS@EMADAMSCO.COM
Phone+1(772)461-0532
EmailEMADAMS@EMADAMSCO.COM
Phone+1(772)461-0532
EmailEMADAMS@EMADAMSCO.COM
Phone+1(772)461-0532
EmailEMADAMS@EMADAMSCO.COM
Phone+1(772)461-0532
EmailEMADAMS@EMADAMSCO.COM
Phone+1(772)461-0532
EmailEMADAMS@EMADAMSCO.COM
Phone+1(772)461-0532
EmailEMADAMS@EMADAMSCO.COM

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS110840200302880 [Primary]
GS150840200302871 [Package]
Contains: 10840200302880
Package: Case [200 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCZSuture Removal Kit

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[50840200302871]

Ethylene Oxide


[50840200302871]

Ethylene Oxide


[50840200302871]

Ethylene Oxide


[50840200302871]

Ethylene Oxide


[50840200302871]

Ethylene Oxide


[50840200302871]

Ethylene Oxide


[50840200302871]

Ethylene Oxide


[50840200302871]

Ethylene Oxide


[50840200302871]

Ethylene Oxide


[50840200302871]

Ethylene Oxide


[50840200302871]

Ethylene Oxide


[50840200302871]

Ethylene Oxide


[50840200302871]

Ethylene Oxide


[50840200302871]

Ethylene Oxide


[50840200302871]

Ethylene Oxide


[50840200302871]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-31
Device Publish Date2021-05-21

On-Brand Devices [E.M Adams co, inc.]

58100013405599ABDOMINAL BINDER
58100013405544ABDOMINAL BINDER
58100013405537ABDOMINAL BINDER
58100013405513LIMB HOLDER
58100013405506LIMB HOLDER
58100013405490LIMB HOLDER
58100013405483LIMB HOLDER
58100013405322LIMB HOLDER
58100013405193POLY BELT
5810001340518650" NYLON STRAP-LOCK
58100013405179POLY BELT
58100013405162POLY BELT
58100013404851POLY BELT
58100013404783UNIVERSAL KNEE SPLINT
58100013404776HAND MITT
58100013404769HAND MITT
58100013404752HAND MITT
58100013404745POLY BELT
58100013404479TUFF CUFF
58100013404462TUFF CUFF
58100013404400TUFF CUFF
58100013404370TUFF CUFF
58100013404363TUFF CUFF
58100013404356TUFF CUFF
58100013404349TUFF CUFF
58100013404332TUFF CUFF
58100013404325TUFF CUFF
58100013404264TUFF CUFF
58100013404257TUFF CUFF
58100013404226LIMB HOLDER
58100013404219TUFF CUFF
58100013404202TUFF CUFF
58100013404097TUFF CUFF
58100013404080TUFF CUFF
58100013404073TUFF CUFF
58100013404066TUFF CUFF
58100013403793TUFF CUFF
58100013403786TUFF CUFF
58100013403779TUFF CUFF
58100013403762TUFF CUFF
58100013403755TUFF CUFF
58100013403748TUFF CUFF
58100013403731TUFF CUFF
58100013403724TUFF CUFF
58100013403717TUFF CUFF
58100013403441POLY BELT
58100013403434POLY BELT
58100013401409ABDOMINAL BINDER
58100013401393ABDOMINAL BINDER
58100013411835SAFETY VEST

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