Pelvic Binder 8003006

GUDID B54180030060

Pelvic Binder, EMS Red

FARETEC, INC.

Pelvic fracture binder, single-use
Primary Device IDB54180030060
NIH Device Record Key4d116ba9-1106-440e-b0ab-894467ca7d6a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePelvic Binder
Version Model NumberPelvic Binder, EMS Red
Catalog Number8003006
Company DUNS626802540
Company NameFARETEC, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone440-350-9510
Emailcolleen@faretec.com
Phone440-350-9510
Emailcolleen@faretec.com
Phone440-350-9510
Emailcolleen@faretec.com
Phone440-350-9510
Emailcolleen@faretec.com
Phone440-350-9510
Emailcolleen@faretec.com
Phone440-350-9510
Emailcolleen@faretec.com
Phone440-350-9510
Emailcolleen@faretec.com
Phone440-350-9510
Emailcolleen@faretec.com
Phone440-350-9510
Emailcolleen@faretec.com
Phone440-350-9510
Emailcolleen@faretec.com
Phone440-350-9510
Emailcolleen@faretec.com
Phone440-350-9510
Emailcolleen@faretec.com
Phone440-350-9510
Emailcolleen@faretec.com
Phone440-350-9510
Emailcolleen@faretec.com
Phone440-350-9510
Emailcolleen@faretec.com
Phone440-350-9510
Emailcolleen@faretec.com
Phone440-350-9510
Emailcolleen@faretec.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB54180030060 [Primary]

FDA Product Code

IPWOrthosis, Sacroiliac, Soft

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-23
Device Publish Date2023-03-15

On-Brand Devices [Pelvic Binder]

B54180030070Pelvic Binder, EMS Red, with traction attachment
B54180030060Pelvic Binder, EMS Red
B54180030040Pelvic Binder, EMS, Blue
B54180030030Pelvic Binder, Tactical, black with traction attachment
B54180030020Pelvic Binder, Tactical, black
B54180030010Pelvic Binder, Military, Camo with traction attachment
B54180030000Pelvic Binder, Military, camo
B54180030050Pelvic Binder, EMS, Blue with traction attachment
B54180030080Pelvic binder, coyote brown

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