FDA.reportPublic FDA data

Binder Lift

Primary DI
00860012552160
Brand
Binder Lift
Company
We Stitch Stuff, LLC
Model
BT-SA3-BL
Catalog number
BT-SA3-BL
Device description
Binder Transfer Anchors (set of 8) for Stryker Pro XT and Pro 2 models
Published
2024-11-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMRDevice, Transfer, Patient, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMRDevice, Transfer, Patient, ManualGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860012552160PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860012552160008600125521608600125521600860012552160

GMDN Terms#

Term, Definition table
TermDefinition
Patient transfer/turning sheet, reusableA manual device in the form of a non-inflatable sheet or mat intended to be used by healthcare professionals to assist in the physical movement and/or transfer of a recumbent patient from one position/location to another. The device may operate using sliding/rolling and/or lifting techniques to move the patient upon it. It is typically made of plastics or textiles and may incorporate handles. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
605-412-8312robin.rowe@westitchstuff.com
855-293-5438admin@phaseintl.com

Regulatory Flags#

DUNS number
124463328
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860012552115Binder LiftBT-FANX7-BLBT-FANX7-BL2024-11-08
00860012552139Binder LiftBT-FAX8-BLBT-FAX8-BL2024-11-08
00860012552184Binder LiftBT-FBX5-BLBT-FBX5-BL2024-11-08
00860010986561Binder LiftBT-SS2-BLBT-SS2-BL2024-08-09
00860012552122Binder LiftBT-FS6-BLBT-FS6-BL2024-08-09
00860010986554Binder LiftBT-SB1-BLBT-SB1-BL2024-08-09
00860012552108Binder LiftBT-FBNX4-BL BT-FBNX4-BL 2024-08-09
00860010986509Binder Lift SV-BL SV-BL 2024-08-09
00860010986516Binder LiftBV-BLBV-BL2024-08-09
00860010986523Binder LiftSN-BLSN-BL2024-08-09
00860010986530Binder LiftBN-BLBN-BL2024-08-09
00860010986578Binder LiftS2-BG-BLS2-BG-BL2024-08-09
00860010986585Binder LiftB2-BLB2-BL2024-08-09
00860010986592Binder LiftB2-BG-BLB2-BG-BL2024-08-09
00860011006800Binder LiftLSR-B-BLLSR-B-BL2024-08-09
00860011006817Binder LiftLSR-S-BLLSR-S-BL2024-08-09
00860011006824Binder LiftLSX-BLLSX-BL2024-08-09
00860011006831Binder LiftBHX4-BLBHX4-BL2024-08-09
00860011006848Binder LiftSV-BG-BLSV-BG-BL2024-08-09
00860011006855Binder LiftBV-BG-BLBV-BG-BL2024-08-09

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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15059441537325AIRPALArjohuntleigh ABFMR2026-03-23
15059441537332AIRPALArjohuntleigh ABFMR2026-03-23
15059441537349AIRPALArjohuntleigh ABFMR2026-03-23
00816299011500HoverCover SlideHovertech InternationalFMR2026-01-12
07613327632842Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCFMR2025-11-19
07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCFMR2025-11-19
0078755104129340649 Air-Assist +XODUS MEDICAL, INC.FMR2025-10-24
0078755104130940650 Air-Assist EXTXODUS MEDICAL, INC.FMR2025-10-24
00816299012569HoverMatt PROS Hovertech InternationalFMR2025-09-10
00816299012576HoverMatt PROS Hovertech InternationalFMR2025-09-10
00816299012781HoverMatt PROS Hovertech InternationalFMR2025-09-10
10197344161249MEDLINEMEDLINE INDUSTRIES, INC.FMR2025-07-11
20197344154958MEDLINEMEDLINE INDUSTRIES, INC.FMR2025-04-23
10193489021141MEDLINEMEDLINE INDUSTRIES, INC.FMR2025-02-14
0078755104000540685 Air Assist Power Lift - 120VACXODUS MEDICAL, INC.FMR2025-02-04
0078755104074640999 Air Assist Power Lift - 220VACXODUS MEDICAL, INC.FMR2025-02-04
10193489000658MEDLINEMEDLINE INDUSTRIES, INC.FMR2025-01-03
10603354130200BAMEHOB INCFMR2024-09-12
10603354130248BAMEHOB INCFMR2024-09-12
10603354130262BAMEHOB INCFMR2024-09-12
10603354130286BAMEHOB INCFMR2024-09-12
10603354130309BAMEHOB INCFMR2024-09-12
10603354130323BAMEHOB INCFMR2024-09-03
10603354130347BAMEHOB INCFMR2024-09-03
10603354130361BAMEHOB INCFMR2024-09-03
10603354130446BAMEHOB INCFMR2024-09-03
10603354130514BAMEHOB INCFMR2024-09-03