FDA.reportPublic FDA data

SchureMed

Primary DI
00810014600826
Brand
SchureMed
Company
SCHUERCH CORPORATION
Model
800-0188-SKY
Catalog number
800-0188-SKY
Device description
ARMBOARD, STANDARD, (EU) (SEE 800-0008)
Published
2019-06-13
Public version status
Update
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
00810014600826PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810014600826008100146008268100146008260810014600826

GMDN Terms#

Term, Definition table
TermDefinition
Arm procedure positioner, reusableA preformed device designed to support and stabilize a patient's arm in a desired position during a medical procedure [e.g., orthopaedic surgery, anaesthesia administration, blood donation, intravenous (IV) infusion, physical therapy massage]. Also known as an arm posturing device or armboard, it is typically constructed as an elongated, curved, cushioned surface, and is typically attached or fixed onto a side rail, operation/examination table, blood donor couch, or a chair, and has adjustable height, tilt, rotation, and lock positioning capabilities. 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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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30653405986373CONMEDConmed CorporationFWZ2026-01-17
20653405990182CONMEDConmed CorporationFWZ2026-01-17
00696588008240De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2025-12-16
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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
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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