FDA.reportPublic FDA data

E.M Adams co, inc.

Primary DI
18100013401241
Brand
E.M Adams co, inc.
Company
E.M. ADAMS, INC.
Model
114-A7006-1
Device description
CIRCUMCISION TRAY
Published
2019-12-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OHGCircumcision Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHGCircumcision TrayObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
58100013401232PackageGS120Not in Commercial Distribution
18100013401241PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5810001340123258100013401232
1810001340124118100013401241

GMDN Terms#

Term, Definition table
TermDefinition
Circumcision kit, single-useA collection of sterile devices designed to perform a circumcision procedure. It typically includes a disinfectant, circumcision clamp, scissors, and a scalpel. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(772)461-0532EMADAMS@EMADAMSCO.COM

Regulatory Flags#

DUNS number
001403807
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840200302309E.M Adams co, inc.14-3444-12021-05-21
18100013402309E.M Adams co, inc.14-3444-12019-12-31
10840200325599E.M. Adams Co Inc14-70809JK-12023-11-21
50840200325580E.M. Adams Co Inc14-70809JK-12023-11-21
10840200325575E.M. Adams Co, Inc114-A3609-12023-11-17
50840200325566E.M. Adams Co, Inc114-A3609-12023-11-17
10840200301081E.M. Adams Co Inc114-A11341-12023-10-31
50840200301072E.M. Adams Co Inc114-A11341-12023-10-31
10840200325551E.M. Adams Co Inc114-31613-12023-10-31
10840200325537E.M. Adams Co, Inc.14-3497-12023-10-20
50840200325528E.M. Adams Co, Inc.14-3497-12023-10-20
10840200325452E.M. Adams co, inc.EP30405L-12023-06-20
50840200325443E.M. Adams co, inc.EP30405L-12023-06-20
10840200302040E.M Adams co, inc.14-3358-12021-05-21
10840200302217E.M Adams co, inc.14-3392-12021-05-21
10840200302248E.M Adams co, inc.14-3393-12021-05-21
18100013401999E.M Adams co, inc.14-3350-12019-12-31
18100013402040E.M Adams co, inc.14-3358-12019-12-31
18100013402217E.M Adams co, inc.14-3392-12019-12-31
18100013402248E.M Adams co, inc.14-3393-12019-12-31

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