FDA.report

Medline-Microtek

Primary DI
00748426263943
Brand
Medline-Microtek
Company
Microtek Medical LLC
Model
Protective Restraints
Catalog number
OPASN
Device description
One Piece OR Table Strap, 10.2 cm x 267 cm (4 in x 105 in)
Published
2026-01-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FMQRestraint, Protective

Product Code Classifications

CodeDeviceSpecialtyClass
FMQRestraint, ProtectiveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20748426263947PrimaryGS10
00748426263943Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2074842626394720748426263947
00748426263943007484262639437484262639430748426263943

GMDN Terms

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

Contacts

PhoneEmail
1(800)633-5463customerservice@medline.com

Regulatory Flags

DUNS number
106908437
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
20748426264487Medline-MicrotekPatient Drapes5960UK2026-03-16
20748426264494Medline-MicrotekEquipment Drapes8033651EU2026-03-16
10748426264503Medline-MicrotekEquipment Drapes49652026-03-16
00748426264315Medline-MicrotekPatient Drapes59602026-02-11
10748426261540NA33206633202026-02-26
10748426144577Medline-MicrotekEquipment Drapes2222505H2026-02-18
10748426144638Medline-MicrotekEquipment Drapes61515RT2026-02-18
10748426144645Medline-MicrotekEquipment Drapes8838M2026-02-18
10748426144690Medline-MicrotekEquipment Drapes9951-202026-02-18
10748426144737Medline-MicrotekEquipment Drapes8900102026-02-18
10748426144744Medline-MicrotekEquipment Drapes8900162026-02-18
10748426144751Medline-MicrotekEquipment Drapes8900172026-02-18
10748426145468Medline-MicrotekEquipment Drapes99042026-02-18
10748426145475Medline-MicrotekEquipment Drapes99072026-02-18
10748426145505Medline-MicrotekEquipment Drapes29042026-02-18
10748426145512Medline-MicrotekEquipment Drapes46042026-02-18
10748426145529Medline-MicrotekEquipment Drapes46242026-02-18
10748426145536Medline-MicrotekEquipment Drapes49542026-02-18
10748426145543Medline-MicrotekEquipment Drapes49732026-02-18
10748426145550Medline-MicrotekEquipment Drapes59002026-02-18

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