FDA.reportPublic FDA data

Straps for 4-020-02-4 (pr.)

Primary DI
10841736112608
Brand
Straps for 4-020-02-4 (pr.)
Company
SKYTRON LLC
Model
4-020-02-2
Device description
Straps for 4-020-02-4 (pr.)
Published
2019-12-01
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LWGSurgical Table Cushion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWGSurgical Table CushionGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841736112608PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084173611260810841736112608

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
800-759-8766info@skytron.us

Regulatory Flags#

DUNS number
078375583
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841736124410Skytron 200 x 400 VESA Adapter Plate4A-VESA-200-400 Freedom4A-VESA-200-4002026-03-19
10841736125141CleanStartCSTART-7115CSTART-71152025-12-19
10841736125158CleanStartCSTART-7130CSTART-71302025-12-19
10841736125165CleanStartCSTART-8115CSTART-81152025-12-19
10841736125172CleanStartCSTART-8130CSTART-81302025-12-19
10841736125189CleanStartCSTART-8315CSTART-83152025-12-19
10841736125196CleanStartCSTART-8330CSTART-83302025-12-19
10841736125202CleanStartCSTART-9815CSTART-98152025-12-19
10841736125219CleanStartCSTART-9830CSTART-98302025-12-19
10841736124298Skytron LLC40-LC-ED40-LC-ED2025-12-09
10841736124427Sterling 1000-MIS-WA1000-MIS-WA2025-12-09
10841736124434Sterling 1800-MIS-WA1800-MIS-WA2025-12-09
10841736124861Skytron4-030-42-94-030-42-92025-12-03
10841736124878Skytron1-012-04-21-012-04-22025-12-03
10841736124885Skytron1-012-04-31-012-04-32025-12-03
10841736124892Skytron1-012-04-41-012-04-42025-12-03
10841736124908Skytron1-012-04-51-012-04-52025-12-03
10841736124915Skytron2-060-05-3S2-060-05-3S2025-12-03
10841736124939Skytron4-030-01-14-030-01-12025-12-03
10841736124946Skytron4-030-10-2WS4-030-10-2WS2025-12-03

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