FDA.reportPublic FDA data

Shoulder immobilizer/orthosis, single-use

Definition
A prefabricated (non-customized) non-rigid wearable device designed to support, align, and/or temporarily immobilize the shoulder joint to support the healing of an injury or surgical wound. It will typically consist of straps, buckles, fasteners, or be in the form of a sling. This is a single-use device.
GUDID devices
83
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
06009544046790N/ASOUTHERN IMPLANTS (PTY) LTDSIB-NL-35-43C1.52024-02-22
00840314812643B-COOL SHOULDER WRAP W/2,2.0 PKHausmann Enterprises, LLCHM33222025-01-01
00645517327020TrulifeTRULIFE LIMITEDJS-15222022-12-31
00645517327037TrulifeTRULIFE LIMITEDJS-15232022-12-31
00645517327044TrulifeTRULIFE LIMITEDJS-15242022-12-31
00645517327051TrulifeTRULIFE LIMITEDJS-15252022-12-31
00645517327068TrulifeTRULIFE LIMITEDJS-15262022-12-31
00645517327075TrulifeTRULIFE LIMITEDJS-15272022-12-31
00645517327082TrulifeTRULIFE LIMITEDJS-15282022-12-31
00645517556253TrulifeTRULIFE LIMITEDGS101L2022-12-31
00645517556260TrulifeTRULIFE LIMITEDGS101R2022-12-31
00645517890869TrulifeTRULIFE LIMITEDGS102L2022-12-31
00645517890876TrulifeTRULIFE LIMITEDGS102R2022-12-31
08809924584472Customized AbutmentARUM DENTISTRY Co., Ltd.CIHE006S2023-05-09
00610570091874SLING & SWATHE IMMOBILIZER XSBird & Cronin, LLC081401612022-08-30
00610570091881SLING & SWATHE IMMOBILIZER 2XLBird & Cronin, LLC081401662022-08-30
00610570095032UNIVERSAL SLING & SWATHE IMMOBBird & Cronin, LLC081401602022-08-30
00610570108121COMFOR SHLDR IMMOB. X-LONG ADULTBird & Cronin, LLC081404722022-08-30
00610570124770B-COOL TERI SHOULDER W/2,2.0 PKSBird & Cronin, LLC081433122022-08-30
00610570124787B-COOL TERI SHOULDER W/2 PKSBird & Cronin, LLC081433132022-08-30
00610570124794B-COOL SHOULDER WRAP W/2 PKSBird & Cronin, LLC081433212022-08-30
00610570124800B-COOL SHOULDER WRAP W/2,2.0 PKBird & Cronin, LLC081433222022-08-30
00610570124817B-COOL SHOULDER WRAP ONLYBird & Cronin, LLC081433232022-08-30
00610570132638UNIV SLING & SWATHE IMMOB X-LONGBird & Cronin, LLC081401592022-08-30
00610570183777B-COOL SHOULDER COLD KITBird & Cronin, LLC900033672022-08-30
00610570185702UNIVERSAL VELPEAU IMMOBILIZERBird & Cronin, LLC081400902022-08-30
00610570188604MESH VELPEAU SHOULDER IMMOB SMBird & Cronin, LLC081420222022-08-30
00610570188611MESH VELPEAU SHOULDER IMMOB MDBird & Cronin, LLC081420232022-08-30
00610570188628MESH VELPEAU SHOULDER IMMOB LGBird & Cronin, LLC081420242022-08-30
00610570188635MESH VELPEAU SHOULDER IMMOB XLBird & Cronin, LLC081420252022-08-30
00610570188932MESH VELPEAU SHOULDER IMMOB XSBird & Cronin, LLC081420212022-08-30
00610570190461VELPEAU IMMOBILIZER/SLING XSBird & Cronin, LLC081400812022-08-30
00610570190478VELPEAU IMMOBILIZER/SLING SMBird & Cronin, LLC081400822022-08-30
00610570190485VELPEAU IMMOBILIZER/SLING MDBird & Cronin, LLC081400832022-08-30
00610570190492VELPEAU IMMOBILIZER/SLING LGBird & Cronin, LLC081400842022-08-30
00610570190508VELPEAU IMMOBILIZER/SLING XLBird & Cronin, LLC081400852022-08-30
00610570191314VELPEAU IMMOBILIZER/SLING XLBird & Cronin, LLC900051452022-08-30
50610570001601VELPEAU IMMOBILIZER/SLING SMBird & Cronin, LLC081401922022-08-30
50610570001618VELPEAU IMMOBILIZER/SLING MDBird & Cronin, LLC081401932022-08-30
50610570001625VELPEAU IMMOBILIZER/SLING LGBird & Cronin, LLC081401942022-08-30
50610570089906VELPEAU IMMOBILIZER/SLING XLBird & Cronin, LLC081401952022-08-30
50610570110785VELPEAU IMMOBILIZER/SLING XSBird & Cronin, LLC081401912022-08-30
00610570001507SLING & SWATHE IMMOBILIZER LGBird & Cronin, LLC081401642022-08-20
00610570001514SLING & SWATHE IMMOBILIZER XLBird & Cronin, LLC081401652022-08-20
00610570002740COMFOR SHLDR IMMOB STRAIGHT UNIVBird & Cronin, LLC081404702022-08-20
00610570002757COMFOR SHLDR IMMOB CONTOUR UNIVBird & Cronin, LLC081404712022-08-20
00610570002795SHOULDER IMMOBILIZER UNIVBird & Cronin, LLC081404752022-08-20
00610570015061"BICRO SHLDR IMMOB ELASTIC 19-23"" XXS"Bird & Cronin, LLC081445002022-08-20
00610570015078"BICRO SHLDR IMMOB ELASTIC 23-27"" XS"Bird & Cronin, LLC081445012022-08-20
00610570015085"BICRO SHLDR IMMOB ELASTIC 27-31"" SM"Bird & Cronin, LLC081445022022-08-20
00610570015092"BICRO SHLDR IMMOB ELASTIC 31-35"" MD"Bird & Cronin, LLC081445032022-08-20
00610570015108"BICRO SHLDR IMMOB ELASTIC 35-39"" LG"Bird & Cronin, LLC081445042022-08-20
00610570015115"BICRO SHLDR IMMOB ELASTIC 39-43"" XL"Bird & Cronin, LLC081445052022-08-20
00610570015122"BICRO SHLDR IMMOB ELASTIC 43-47"" 2XL"Bird & Cronin, LLC081445062022-08-20
00610570015351COMFOR SHLDR IMMOB CHILD UNIVBird & Cronin, LLC081447022022-08-20
00610570026166COMFOR SHOULDER ABD PILLOW UNVBird & Cronin, LLC081481952022-08-20
00610570057849"SHOULDER IMMOB. 27-35"" SM ADLT"Bird & Cronin, LLCS25457082022-08-20
00610570088188B-COOL TERI SHOULDER WRAP ONLYBird & Cronin, LLC081433902022-08-20
00610570088195B-COOL TERI SHOULDER WRAP W/4PKSBird & Cronin, LLC081433912022-08-20
00610570101283HUMERAL FRAC W/SHOULDER SMBird & Cronin, LLC081472622022-08-20
00610570101290HUMERAL FRAC W/SHOULDER MDBird & Cronin, LLC081472632022-08-20
00610570101306HUMERAL FRAC W/SHOULDER LGBird & Cronin, LLC081472642022-08-20
00610570101313HUMERAL FRAC W/SHOULDER XLBird & Cronin, LLC081472652022-08-20
00610570126965VELPEAU IMMOBILIZER LGBird & Cronin, LLC900001942022-08-20
00610570127184VELPEAU IMMOBILIZER SMBird & Cronin, LLC900001922022-08-20
00610570127207VELPEAU IMMOB XLBird & Cronin, LLC900001952022-08-20
00610570136834Universal Shoulder ImmobilizerBird & Cronin, LLC0818OSG304S2022-08-20
00610570136841Velpeau Shoulder ImmobilizerBird & Cronin, LLC0818OSG30312022-08-20
00610570136988Velpeau Shoulder ImmobilizerBird & Cronin, LLC0818OSG30322022-08-20
00610570136995Velpeau Shoulder ImmobilizerBird & Cronin, LLC0818OSG30332022-08-20
00610570137008Velpeau Shoulder ImmobilizerBird & Cronin, LLC0818OSG30342022-08-20
00610570137015Universal Shoulder ImmobilizerBird & Cronin, LLC0818OSG304C2022-08-20
00610570137770VELPEAU IMMOBILIZER XSBird & Cronin, LLC900021912022-08-20
00610570137787VELPEAU IMMOBILIZER SMBird & Cronin, LLC900021922022-08-20
00610570148318B-COOL SHOULDER WRAP W/2, 2.0 PKSBird & Cronin, LLC900093232022-08-20
00610570148806B-COOL SHOULDER WRAP THERAPY KITBird & Cronin, LLC900033712022-08-20
00610570170098SHOULDER IMMOBILIZER UNIVBird & Cronin, LLC900004752022-08-20
00610570191277VELPEAU IMMOBILIZER/SLING SMBird & Cronin, LLC900051422022-08-20
00610570191284VELPEAU IMMOBILIZER/SLING MDBird & Cronin, LLC900051432022-08-20
00610570191291VELPEAU IMMOBILIZER/SLING LGBird & Cronin, LLC900051442022-08-20