FDA.reportPublic FDA data

Pelvic Binder

Primary DI
B54180030000
Brand
Pelvic Binder
Company
FARETEC, INC.
Model
Pelvic Binder, Military
Catalog number
8003000
Device description
Pelvic Binder, Military, camo
Published
2023-03-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IPWOrthosis, Sacroiliac, Soft

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPWOrthosis, Sacroiliac, SoftPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B54180030000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pelvic fracture binder, single-useA belt-like support designed to be wrapped tightly around the pelvis (around the greater trochanters) of a patient suspected of a pelvic fracture to support the pelvis during transportation. Sometimes referred to as a pelvic belt or sling, it is typically intended to be used in an emergency setting. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
440-350-9510colleen@faretec.com

Regulatory Flags#

DUNS number
626802540
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B54133311420IFAKUNICEF IFAK KIT33311422026-05-12
B54133311410IFAKIFAK LOT 4 33311412026-01-12
B54133311400IFAKIFAK 51 (Ind. First Aid Kit)33311402025-06-19
B54133311390IFAKIFAK 5033311392025-04-18
B54133311380IFAKIFAK 4933311382025-03-28
B54133311370IFAKIFAK 4833311372025-03-14
B54133310470IFAKCombat Casualty IFAK (DLIFAK)33310472025-02-26
B54133311360IFAKIFAK 4733311362025-01-31
B54170019070IFAKTactical Medical Kit, Backpack70019072025-01-31
B54170019080IFAKTactical Medical Bag-Component70019082025-01-31
B54133311350IFAKIFAK 4633311352024-12-11
B54133311340IFAKUN IFAK Advanced Lot 3 Plus33311342024-12-04
B54133311320IFAKIFAK Kit Advanced33311322024-06-14
B54133311310IFAKIFAK 4433311312024-06-10
B54133311300IFAKUN IFAK Advanced33311302024-05-09
B54180030080Pelvic BinderPelvic Binder, Coyote Brown80030082024-02-28
B54133311280IFAKIFAK 4333311282024-01-26
B54133311250IFAKIFAK 4033311252023-12-20
B54133311260IFAKIFAK 4133311262023-12-20
B54133311270IFAKIFAK 4233311272023-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04823097717769"TM ""Rehabilitimed"" GR-3P XXL Comfort"REABILITIMED TOVIPW2025-05-05
04823097717776"TM ""Rehabilitimed"" GR-3P XL Comfort"REABILITIMED TOVIPW2025-05-05
04823097717783"TM ""Rehabilitimed"" GR-3P L Comfort"REABILITIMED TOVIPW2025-05-05
04823097717790"TM ""Rehabilitimed"" GR-3P M Comfort"REABILITIMED TOVIPW2025-05-05
04823097717806"TM ""Rehabilitimed"" GR-3P S Comfort"REABILITIMED TOVIPW2025-05-05
04823097719794"TM ""Rehabilitimed"" GR-3P S Comfort"REABILITIMED TOVIPW2025-05-05
04823097719800"TM ""Rehabilitimed"" GR-3P M Comfort"REABILITIMED TOVIPW2025-05-05
04823097719817"TM ""Rehabilitimed"" GR-3P L Comfort"REABILITIMED TOVIPW2025-05-05
04823097719824"TM ""Rehabilitimed"" GR-3P XL Comfort"REABILITIMED TOVIPW2025-05-05
04823097719831"TM ""Rehabilitimed"" GR-3P XXL Comfort"REABILITIMED TOVIPW2025-05-05
B54180030080Pelvic BinderFARETEC, INC.IPW2024-02-28
B54180030050Pelvic BinderFARETEC, INC.IPW2023-03-16
B54180030010Pelvic BinderFARETEC, INC.IPW2023-03-15
B54180030020Pelvic BinderFARETEC, INC.IPW2023-03-15
B54180030030Pelvic BinderFARETEC, INC.IPW2023-03-15
B54180030040Pelvic BinderFARETEC, INC.IPW2023-03-15
B54180030060Pelvic BinderFARETEC, INC.IPW2023-03-15
B54180030070Pelvic BinderFARETEC, INC.IPW2023-03-15
00822045428614SAM Pelvic Sling IISAM Medical ProductsIPW2022-09-01
00822045428621SAM Pelvic Sling IISAM Medical ProductsIPW2022-09-01
00822045428638SAM Pelvic Sling IISAM Medical ProductsIPW2022-09-01
00822045428645SAM Pelvic Sling IISAM Medical ProductsIPW2022-09-01
10822045428611SAM Pelvic Sling IISAM Medical ProductsIPW2022-09-01
10822045428628SAM Pelvic Sling IISAM Medical ProductsIPW2022-09-01
10822045428635SAM Pelvic Sling IISAM Medical ProductsIPW2022-09-01
10822045428642SAM Pelvic Sling IISAM Medical ProductsIPW2022-09-01
04250105612912n.a.VBM Medizintechnik GmbHIPW2020-08-31
14250105612919n.a.VBM Medizintechnik GmbHIPW2020-08-31
04250105612905n.a.VBM Medizintechnik GmbHIPW2020-08-26
04250105623208n.a.VBM Medizintechnik GmbHIPW2020-08-26