FDA.reportPublic FDA data

MedSource Straps

Primary DI
00816703028261
Brand
MedSource Straps
Company
MEDSOURCE INTERNATIONAL LLC
Model
MS-ST597-RCS
Catalog number
Not Applicable
Device description
METAL BUCKLE W/ LOOP END, 5' RED
Published
2021-08-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
CCXSupport, Patient Position

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816703028261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816703028261008167030282618167030282610816703028261

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

Regulatory Flags#

DUNS number
041674552
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840155400108MedSource Non-Rebreather MaskMS-25058-RCSNot Applicable2021-05-26
00840155400184MedSource Non-Rebreather MaskMS-25060-RCSNot Applicable2021-05-27
00840155400375MedSource Oxygen MaskMS-26041-RCSNot Applicable2021-05-28
00840155400412MedSource Oxygen MaskMS-26042-RCSNot Applicable2021-05-28
00840155408425MedSource BlanketMS-40521Not Applicable2021-07-07
00816703023617MedSource First Aid KitNORTH-349000Not Applicable2021-08-17
00816703023723MedSource BagsNORTH-678805EMNot Applicable2021-08-17
00816703023839MedSource First Aid WalletNORTH-67M08Not Applicable2021-08-25
00816703024034MedSource Packed BagsSH-B1311Not Applicable2021-08-25
00840155404304MedSource Body BagsMS-BOD200Not Applicable2021-07-28
00840155406094MedSource Emergency BlanketMS-B100Not Applicable2021-07-27
00840155406162MedSource Emergency BlanketMS-B200Not Applicable2021-07-27
00816703023853MedSource BagsNORTH-67M09Not Applicable2021-08-25
00816703023860MedSource BagsNORTH-67M10Not Applicable2021-08-25
00816703023938MedSource Packed BagsNORTH-90LGTRAUMNot Applicable2021-08-25
00816703023952MedSource Packed BagsNORTH-90TRAUMAENot Applicable2021-08-25
00816703024058MedSource First Aid KitSH-B1411Not Applicable2021-08-25
00816703024065MedSource Packed BagsSH-B1412Not Applicable2021-08-25
00816703027097MedSource BagsMS-TLS-3-BNot Applicable2021-08-16
00816703029473MedSource BagsMS-33360-RCSNot Applicable2021-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00787551041668LPK10037 Lateral Positioning KitXODUS MEDICAL, INC.CCX2026-10-19
00787551041675LPK10036 Lateral Positioning KitXODUS MEDICAL, INC.CCX2026-10-19
00787551041682SPK10756 Surgical BackPack KitXODUS MEDICAL, INC.CCX2026-10-19
00860003986844GENESIS BI-WING XL GEN 3.0Infinitus Medical Technologies LLCCCX2026-10-15
00860014205507PNEUMA GENESIS BI-WIUNG POSITIONING SYSTEMInfinitus Medical Technologies LLCCCX2026-10-15
09421905187794Adept Medical Lateral Support SingleADEPT MEDICAL LIMITEDCCX2026-10-05
09421905187800Adept Medical Lateral Support PairADEPT MEDICAL LIMITEDCCX2026-10-05
09421905187817Adept Medical Lateral Vacuum BraceADEPT MEDICAL LIMITEDCCX2026-10-05
15060797554775NADavid Scott CompanyCCX2026-09-25
00850047863799SurgiLockMedicalock CorporationCCX2026-09-24
00850047863829SurgiLockMedicalock CorporationCCX2026-09-24
00850047863836CerviLockMedicalock CorporationCCX2026-09-24
00749756401739DeRoyalDEROYAL INDUSTRIES, INC.CCX2026-09-18
00848530109783Oxygen AccessorySunset Healthcare Solutions, Inc.CCX2026-09-09
00787551041637SPK11761 Jackson Table KitXODUS MEDICAL, INC.CCX2026-07-27
00787551041644SPK11773 Surgical BackPack KitXODUS MEDICAL, INC.CCX2026-07-27
00787551041651SPK11774 Surgical BackPack KitXODUS MEDICAL, INC.CCX2026-07-27
00851440007902Responsive Respiratory, Inc.RESPONSIVE RESPIRATORY, INC.CCX2026-07-22
00811836030907TrenGuard™Dan Allen Surgical LLCCCX2026-06-26
00811836030921TrenGuard™Dan Allen Surgical LLCCCX2026-06-26
20811836030215TrenGuard™Dan Allen Surgical LLCCCX2026-06-26
00860014205514TruBlu HDP BootlinersInfinitus Medical Technologies LLCCCX2026-06-05
00860014205521TruBlu HDP, Smith+Nephew Hip Positioning SystemInfinitus Medical Technologies LLCCCX2026-06-05
00860014205538TruBlu HDP, Hana Hip Positioning SystemInfinitus Medical Technologies LLCCCX2026-06-05
00814247021304Panniculus Retraction KitCLINICAL INNOVATIONS, LLCCCX2026-05-31
00814247021311Panniculus Retraction Kit: traxi and ABBy - SmallCLINICAL INNOVATIONS, LLCCCX2026-05-31
00814247021328Panniculus Retraction Kit: traxi and ABBy - LargeCLINICAL INNOVATIONS, LLCCCX2026-05-31
10080196413737MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-04-27
10080196413256MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
10080196413485MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30