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
00822045000179SAM Chest SealCS201-EN2022-09-01
00822045000407SAM SplintSP527-CH-EN-7572022-09-01
00822045000414SAM SplintSP527-OB-EN-5622022-09-01
00822045000438SAM SplintSP527-CH-EN-7732022-09-01
00822045000476SAM SplintSP527-OB-EN-7482022-09-01
00822045000537SAM SplintSP527-OB-EN-8032022-09-01
00822045000544SAM SplintSP527-OB-EN-8042022-09-01
00822045000551SAM Splint XLSP528-CH-EN-7862022-09-01
00822045000575SAM Splint XLSP528-OB-EN-7492022-09-01
00822045000599SAM Splint XLSP528-OB-EN-7742022-09-01
00822045000612SAM SplintSP526-CH-EN-7452022-09-01
00822045000643SAM SplintSP526-BC-EN-7052022-09-01
00822045000667SAM SplintSP526-OB-EN-5052022-09-01
00822045000698SAM SplintSP526-OB-EN-5682022-09-01
00822045000728SAM SplintSP526-OB-EN-7152022-09-01
00822045000742SAM SplintSP526-OB-EN-7722022-09-01
00822045000865SAM SplintSP522-OB-EN-7692022-09-01
00822045000872SAM SplintSP522-CH-EN-7702022-09-01
00822045000896SAM SplintSP524-OB-EN-7712022-09-01
00822045000902SAM SplintSP520-OB-EN-7672022-09-01

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