FDA.report

E.M Adams co, inc.

Primary DI
50840200304783
Brand
E.M Adams co, inc.
Company
E.M. ADAMS, INC.
Model
3030
Device description
UNIVERSAL KNEE SPLINT
Published
2021-12-04
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
false

Related Records

Contact Domains

Product Codes

CodeName
HSPSplint, Traction

Product Code Classifications

CodeDeviceSpecialtyClass
HSPSplint, TractionOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50840200304783PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5084020030478350840200304783

GMDN Terms

TermDefinition
Padded stays splint, reusableA non-sterile padded device designed to immobilize and protect an injured body extremity (arm or leg) during the healing process. It is in the form of a preshaped rigid mould (with padding) intended to be held in place with straps/bandages (not included); it is not primarily intended for use in an emergency setting and is not intended for chronic/long-term use after healing. This is a reusable 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

Other Devices From This Company

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50840200325580E.M. Adams Co Inc14-70809JK-12023-11-21
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50840200301072E.M. Adams Co Inc114-A11341-12023-10-31
10840200325551E.M. Adams Co Inc114-31613-12023-10-31
50840200325528E.M. Adams Co, Inc.14-3497-12023-10-20
50840200325443E.M. Adams co, inc.EP30405L-12023-06-20
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50840200313587E.M. ADAMS CO, INC26-0615XXXXL-12022-07-17
50840200313624E.M. ADAMS CO, INC26-0644-12022-07-17
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50840200314744E.M. ADAMS CO, INCEP28-30205B-12022-07-17
50840200314768E.M. ADAMS CO, INCEP28-30205G-12022-07-17
50840200314782E.M. ADAMS CO, INCEP28-30205U-12022-07-17
50840200314805E.M. ADAMS CO, INCEP28-30206B-12022-07-17
50840200314843E.M. ADAMS CO, INCEP28-30206U-12022-07-17
50840200314867E.M. ADAMS CO, INCEP28-30207B-12022-07-17
50840200314881E.M. ADAMS CO, INCEP28-30207G-12022-07-17

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