FDA.reportPublic FDA data

SAM Pelvic Sling II

Primary DI
00822045428638
Brand
SAM Pelvic Sling II
Company
SAM Medical Products
Model
PS301-OB-EN
Device description
SAM PELVIC SLING STANDARD
Published
2022-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
OTC
true
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
10822045428635PackageGS124In Commercial Distribution
00822045428638PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082204542863510822045428635
00822045428638008220454286388220454286380822045428638

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.

Contacts#

Phone, Email table
PhoneEmail
5036395474raqa@sammedical.com

Regulatory Flags#

DUNS number
131084188
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00822045428805SAM Soft Shell SplintSS544-EN2022-09-01
00822045428812SAM Soft Shell Splint XLSS545-EN2022-09-01
00822045428836SAM Soft Shell SplintSS542-EN2022-09-01
00822045428843SAM Soft Shell Splint XLSS543-EN2022-09-01
00822045428867SAM Soft Shell SplintSS540-EN2022-09-01
00822045428874SAM Soft Shell Splint XLSS541-EN2022-09-01
00822045428881SAM Sugar Tong SplintST560-EN2022-09-01
00822045428898SAM Sugar Tong SplintST561-EN2022-09-01
00822045428935SAM Sugar Tong SplintST562-EN2022-09-01
00822045001503SAM ThoraSite®TS200-1P2025-12-12
10822045000305SAM IO Intraosseous Access SystemIO740-5P-EN2020-05-28
00822045000308SAM IO Intraosseous Access SystemIO740-1P-EN2020-05-28
00822045000001Chito-SAM™ 100CT100-C-EN2022-09-01
00822045000025Chito-SAM™ 100CT100-A-EN2022-09-01
00822045000339Chito-SAM™ 100CT100-B-EN2022-09-01
00822045000926SAM XT Extremity TourniquetXT700-BL-EN2024-11-14
00822045001039SAM XT Extremity TourniquetXT700-OR-EN2024-11-14
00822045000889SAM XT Extremity TourniquetXT700-BK-EN2024-11-14
10822045000923SAM XT Extremity TourniquetXT700-BL-EN2024-11-14
10822045001036SAM XT Extremity TourniquetXT700-OR-EN2024-11-14

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
B54180030000Pelvic BinderFARETEC, INC.IPW2023-03-15
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
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