FDA.report

E.M Adams co, inc.

Primary DI
58100013400792
Brand
E.M Adams co, inc.
Company
E.M. ADAMS, INC.
Model
114-3184-1
Device description
CIRCUMCISION TRAY
Published
2019-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
OHGCircumcision Tray

Product Code Classifications

CodeDeviceSpecialtyClass
OHGCircumcision TrayObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
58100013400792PackageGS120In Commercial Distribution
18100013400800PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5810001340079258100013400792
1810001340080018100013400800

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Ethylene Oxide

Contacts

PhoneEmail
+1(772)461-0532EMADAMS@EMADAMSCO.COM

Regulatory Flags

DUNS number
001403807
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
true

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