FDA.report

SchureMed

Primary DI
00810014600154
Brand
SchureMed
Company
SCHUERCH CORPORATION
Model
800-0039
Catalog number
800-0039
Device description
DISPOSABLE HEAD & CHIN STRAPS (12/CS)
Published
2019-02-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
BTKStrap, Head, Gas Mask
FWZOperating Room Accessories Table Tray

Product Code Classifications

CodeDeviceSpecialtyClass
BTKStrap, Head, Gas MaskAnesthesiology1
FWZOperating Room Accessories Table TrayGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
01810014600153PackageGS11Not in Commercial Distribution
00810014600154PrimaryGS10
00810014600147Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
01810014600153018100146001531810014600153
00810014600154008100146001548100146001540810014600154
00810014600147008100146001478100146001470810014600147

GMDN Terms

TermDefinition
Head/neck immobilizer, single-useA rigid or non-rigid, non-sterile, device usually made of fabric and/or plastic materials, used to temporarily render the head/neck of a patient immovable to ensure immobilization when a head and/or spinal injury is suspected. It is used in conjunction with serious accidents and for transport of the patient on a stretcher and possibly in conjunction with a spinal board to which this device and the patient are strapped. It is typically made of x-ray translucent/non-ferromagnetically active materials that allow x-ray and magnetic resonance imaging (MRI) and comes in various sizes. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
781-982-7000lisa@schuremed.com

Regulatory Flags

DUNS number
964322929
Device count
12
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
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 DIBrandModelCatalogPublished
00810014601946SchureMed800-0142-SKY3-040-302019-06-13
00810014602974SchureMed800-0164-SKY3-040-33-12019-06-13
00810057373138SchureMed508-15402021-09-22
00810057373794SchureMed800-0142-S-EU2021-09-10
00810014602912SchureMed800-00062021-09-02
00810014603605SchureMed508-0373508-03732021-09-02
00810057371578SchureMed790-0079-N2021-09-02
00810057373787SchureMed800-0142-S2021-09-02
00841036239640SchureMed800-0134-Z2021-09-02
00810014604466SchureMed508-00912020-10-05
00081005737313SchureMed508-15402021-08-12
00810014601137SchureMed800-02802021-08-12
00810014601816SchureMed800-01002021-08-12
00810014602226SchureMed800-0280-DEN2021-08-12
00810014603483SchureMed800-0125-EU2021-08-12
00810014603506SchureMed800-01252021-08-12
00810057371615SchureMed990-00502021-08-12
00810057371622SchureMed990-0050-OEM2021-08-12
00810057371639SchureMed990-0050-HD2021-08-12
00810057371646SchureMed990-0050-R2021-08-12

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