FDA.reportPublic FDA data

NA

Primary DI
00724995157869
Brand
NA
Company
STERIS CORPORATION
Model
Restraint Strap
Catalog number
BF111
Device description
The Wristlets with Straps and Brackets are leather wristlets support and secure wrists and forearms while patient is in supine operative position.
Published
2021-04-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMQRestraint, protective

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMQRestraint, ProtectiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995157869PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995157869007249951578697249951578690724995157869

GMDN Terms#

Term, Definition table
TermDefinition
Limb/torso/head restraint, reusableA non-rigid device, typically a strap(s) or 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 reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
036985604
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995232016NAX-Ray Table TopBF5532026-05-26
00724995232023NAX-Ray Table TopBF5542026-05-26
00724995232030NATable ExtenderBF5552026-05-26
00724995232054NAX-Ray Table TopBF6622026-05-26
00724995232061NAX-Ray Table TopBF6632026-05-26
00724995232078NAX-Ray Table TopBF6642026-05-26
10724995165250NAX-Ray Table TopBF6632021-04-02
10724995165281NAX-Ray Table TopBF6642021-04-02
10724995245457HexaLuxEXLHAN3EXLHAN32025-05-05
00724995165161NAX-Ray Table TopBF5532021-04-02
00724995165178NATable ExtenderBF5552021-04-02
00724995165185NAX-Ray Table TopBF5542021-04-02
00724995165222NAX-Ray Table TopBF6622021-04-02
10885403018862V. MuellerCD0-3BCD03B2017-11-17
10885403018879V. MuellerCD0-3CCD03C2017-11-17
10885403018893V. MuellerCD0-4BCD04B2017-11-17
10885403018909V. MuellerCD0-4CCD04C2017-11-17
10885403018947V. MuellerCD1-4BCD14B2017-11-17
10885403018954V. MuellerCD1-4CCD14C2017-11-17
10885403018985V. MuellerCD1-5BCD15B2017-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196310128MEDLINEMEDLINE INDUSTRIES, INC.FMQ2025-06-03
10748426141125Medline-MicrotekMicrotek Medical LLCFMQ2025-04-08
09010279001708iFIXiSYS Medizintechnik GmbHFMQ2024-07-30
09010279001715iFIXiSYS Medizintechnik GmbHFMQ2024-07-30
10080196281374MedlineMEDLINE INDUSTRIES, INC.FMQ2024-05-01
M1435040070Protective Vest No SleeveKenad SG Medical, Inc.FMQ2023-09-17
10810087352766CoulmedCoulmed Products Group LLCFMQ2023-01-06
10810087353022CoulmedCoulmed Products Group LLCFMQ2023-01-06
10810087353039CoulmedCoulmed Products Group LLCFMQ2023-01-06
10810087353046CoulmedCoulmed Products Group LLCFMQ2023-01-06
10810087353053CoulmedCoulmed Products Group LLCFMQ2023-01-06
10190676003232POSEYPOSEY PRODUCTS, LLCFMQ2022-10-06
10190676003348POSEYPOSEY PRODUCTS, LLCFMQ2022-10-06
10190676003355POSEYPOSEY PRODUCTS, LLCFMQ2022-10-06
10190676005441POSEYPOSEY PRODUCTS, LLCFMQ2022-10-06
10190676005458POSEYPOSEY PRODUCTS, LLCFMQ2022-10-06
10190676005465POSEYPOSEY PRODUCTS, LLCFMQ2022-10-06
10190676001016POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676001085POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676001108POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002518POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002525POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002532POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002549POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002556POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002563POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002570POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002594POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002600POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002617POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05