FDA.reportPublic FDA data

"3"" CHILDRENS O.R. TABLE STRAP"

Primary DI
00610570129720
Brand
"3"" CHILDRENS O.R. TABLE STRAP"
Company
Bird & Cronin, LLC
Model
S2246303
Published
2022-08-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
IODComponents, Exercise

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IODComponents, ExercisePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00610570129720PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00610570129720006105701297206105701297200610570129720

GMDN Terms#

Term, Definition table
TermDefinition
Limb/torso/head restraint, single-useA non-rigid device, typically a strap(s), band(s) or garment-like, intended to be temporarily placed on or around one or more parts of a patient’s body (e.g., torso, limbs, head) to restrict movement, to facilitate patient positioning and stabilization during a medical procedure, and/or to prevent injury/hazards while potentially permitting limited movement. It is made of various materials (e.g., fabric, nylon, leather, or foam) and typically anchored to a fixture or furniture part (e.g., a bedrail, operating table). It is not intended for immobilization of specific joint. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
045975349
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00610570187386BULB HOLDER081482202022-10-31
00610570176519CHAS CATH-MATE STRAP081482002022-08-30
00610570176526CATH-MATE II CATHETER STRAP081482142022-08-30
00610570176786CHAS II CATH-MATE STRAP081482012022-08-30
00610570187379"CATH-MATE II X-LONG STRAP 28"""081482132022-08-30
50610570189552PRODY DRAINAGE BULB HOLDER II081477202022-08-30
00610570142309CHAS CATH-MATE STRAP 2/PK500082002022-08-20
00610570145584BULB HOLDER KIT081482212022-08-20
00610570157839"9"" ABD W/DRAIN HLDR UP TO 45"""081482262022-08-20
00610570157846"9"" ABD W/DRAIN HLDR 46-62"""081482272022-08-20
00610570157853"9"" ABD W/DRAIN HLDR 55-72"""081482282022-08-20
00610570165285"6"" ABD W/DRAIN HLDR UP TO 60"""081482302022-08-20
00610570165889"12"" ABD W/DRAIN HLDR UP TO 45"""081482362022-08-20
00610570165902"12"" ABD W/DRAIN HLDR 46-62"""081482372022-08-20
00610570165919"12"" ABD W/DRAIN HLDR 55-72"""081482382022-08-20
00610570165926"12"" ABD W/DRAIN HLDR 72-96"""081482392022-08-20
00610570189564PRODY DRAINAGE BULB HOLDER II KIT081477212022-08-20
00610570189571"PRODY 9"" ABD II W/DRAIN HLDR UP TO 45"""081477262022-08-20
00610570189588"PRODY 9"" ABD II W/DRAIN HLDR 46-62"""081477272022-08-20
00610570189595"PRODY 9"" ABD II W/DRAIN HLDR 55-72"""081477282022-08-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840314816108"STAIRS,TIMBER,MINI STRAIGHT,2 6""STEPS,3"Hausmann Enterprises, LLCIOD2025-04-14
00840314816122"STAIRS,TIMBER,SINGLE-SIDE,4 6""STEPS"Hausmann Enterprises, LLCIOD2025-04-14
00810113576367ViveVIVE HEALTH LLCIOD2024-08-20
10810113576364ViveVIVE HEALTH LLCIOD2024-08-20
00810113574356ViveVIVE HEALTH LLCIOD2024-07-17
00810113577296ViveVIVE HEALTH LLCIOD2024-07-17
10810113574353ViveVIVE HEALTH LLCIOD2024-07-17
10810113577293ViveVIVE HEALTH LLCIOD2024-07-17
00057475571184BIOS LivingThermor LtdIOD2023-09-18
10057475571181BIOS LivingThermor LtdIOD2023-09-18
00810113573403ViveVIVE HEALTH LLCIOD2023-08-23
10810113573400ViveVIVE HEALTH LLCIOD2023-08-23
00818323029529ViveVIVE HEALTH LLCIOD2023-08-02
00818323029536ViveVIVE HEALTH LLCIOD2023-08-02
10818323029526ViveVIVE HEALTH LLCIOD2023-08-02
10818323029533ViveVIVE HEALTH LLCIOD2023-08-02
G505MRBHS0Balance Harness M.A.S.S. Rehab, LLCIOD2023-08-01
G505MRHSH0Healing Solutions HarnessM.A.S.S. Rehab, LLCIOD2023-08-01
G505MRUHB0Unloading Harness BariatricM.A.S.S. Rehab, LLCIOD2023-08-01
G505MRUHS0Unloading HarnessM.A.S.S. Rehab, LLCIOD2023-08-01
00840252911828Dig-o-meterTherafin CorporationIOD2023-07-06
00810041982353VIVEVIVE HEALTH LLCIOD2023-06-30
10810041982350VIVEVIVE HEALTH LLCIOD2023-06-30
07290019733003HandTutorMEDITOUCH LTDIOD2023-06-21
07290019733836TutorCart WorkStationMEDITOUCH LTDIOD2023-06-21
07290019733843TutorCart WorkStationMEDITOUCH LTDIOD2023-06-21
072900197338503DTutor StationMEDITOUCH LTDIOD2023-06-21
072900197338673DTutorMEDITOUCH LTDIOD2023-06-21
07290019733874LegTutorMEDITOUCH LTDIOD2023-06-21
07290019733881LegTutorMEDITOUCH LTDIOD2023-06-21