FDA.report

E.M Adams co, inc.

Primary DI
50840200305599
Brand
E.M Adams co, inc.
Company
E.M. ADAMS, INC.
Model
9038
Device description
ABDOMINAL BINDER
Published
2021-12-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FSDBinder, Abdominal

Product Code Classifications

CodeDeviceSpecialtyClass
FSDBinder, AbdominalGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50840200305599PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5084020030559950840200305599

GMDN Terms

TermDefinition
Abdominal binder, single-useA strip, roll or tube of fabric or polymer material intended to be applied to the abdomen to support relaxed abdominal walls (e.g., after surgery, during pregnancy) or to provide support for another device (e.g., dressing, ultrasound transducer, percutaneous lead). This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

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

Regulatory Flags

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

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