FDA.reportPublic FDA data

SchureMed

Primary DI
00810057372230
Brand
SchureMed
Company
SCHUERCH CORPORATION
Model
800-0387
Device description
Silhouetted Headrest
Published
2021-03-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FWZOperating Room Accessories Table Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWZOperating Room Accessories Table TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810057372230PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810057372230008100573722308100573722300810057372230

GMDN Terms#

Term, Definition table
TermDefinition
Head/neck procedure positionerA noninvasive device consisting of fixed or adjustable elements (e.g., frame, board, multi-jointed structure) designed to ensure adequate support, positioning and immobilization of the patient's head, neck, and cervical spine during intraoperative procedures (e.g., cervical spine or brain surgery) or diagnostic imaging (e.g., dental x-ray procedures). It is typically mounted on an operating/examination table and allows adjustment of the height and angle of the head. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(781)982-7000Lisa@SchureMed.com

Regulatory Flags#

DUNS number
964322929
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260217222176AMTRION Claw 4025Amtrion GmbHFWZ2026-05-26
00696588008257De Mayo Universal Distractor®Innovative Medical Products, IncFWZ2026-01-20
10653405986362CONMEDConmed CorporationFWZ2026-01-17
30653405986373CONMEDConmed CorporationFWZ2026-01-17
20653405990182CONMEDConmed CorporationFWZ2026-01-17
00696588008240De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2025-12-16
00696588008165De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2025-09-17
00696588008172De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2025-09-17
00696588008141De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2025-08-28
00696588008158De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2025-08-28
00696588008127De Mayo D2® Knee Positioner®Innovative Medical Products, IncFWZ2025-08-18
00696588008134De Mayo D2® Knee Positioner®Innovative Medical Products, IncFWZ2025-08-18
00696588008110De Mayo Universal Distractor®Innovative Medical Products, IncFWZ2025-08-11
00696588008073De Mayo Knee Positioner®Innovative Medical Products, IncFWZ2025-08-05
00696588008080De Mayo Knee Positioner®Innovative Medical Products, IncFWZ2025-08-05
00696588008097De Mayo D2® Knee Positioner®Innovative Medical Products, IncFWZ2025-07-28
00696588008103De Mayo D2® Knee Positioner®Innovative Medical Products, IncFWZ2025-07-28
00696588008066De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2025-06-30
00696588008035Exact-Fit® De Mayo Lateral Positioner®Innovative Medical Products, IncFWZ2025-06-04
00696588008042Exact-Fit® De Mayo Lateral Positioner®Innovative Medical Products, IncFWZ2025-06-04
00696588008059Exact-Fit® De Mayo Lateral Positioner®Innovative Medical Products, IncFWZ2025-06-04
00696588008028MorphBoard®Innovative Medical Products, IncFWZ2025-05-28
00696588007960MorphBoard®Innovative Medical Products, IncFWZ2025-05-08
00696588007977MorphBoard®Innovative Medical Products, IncFWZ2025-05-08
00696588007984MorphBoard®Innovative Medical Products, IncFWZ2025-05-08
00696588007991MorphBoard®Innovative Medical Products, IncFWZ2025-05-08
00696588008004MorphBoard®Innovative Medical Products, IncFWZ2025-05-08
00696588008011MorphBoard®Innovative Medical Products, IncFWZ2025-05-08
00724995245016ClampSTERIS CORPORATIONFWZ2025-05-05
00696588007922UKnee Suspended Knee PositionerInnovative Medical Products, IncFWZ2025-04-09