FDA.reportPublic FDA data

SAM Pelvic Sling II

Primary DI
10822045428628
Brand
SAM Pelvic Sling II
Company
SAM Medical Products
Model
PS300-OB-EN
Device description
SAM PELVIC SLING SMALL
Published
2022-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
true
Sterile
false
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
10822045428628PackageGS124In Commercial Distribution
00822045428621PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082204542862810822045428628
00822045428621008220454286218220454286210822045428621

GMDN Terms#

Term, Definition table
TermDefinition
Pelvic binder, single-useA non-sterile, 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. It is typically intended to be used in an emergency setting to stabilize pelvic fractures. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5036395474raqa@sammedical.com

Regulatory Flags#

DUNS number
131084188
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
false
No natural rubber latex
false
Sterilization required before use
false

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
00822045428638SAM Pelvic Sling IISAM Medical ProductsIPW2022-09-01
00822045428645SAM Pelvic Sling IISAM Medical ProductsIPW2022-09-01
10822045428611SAM 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