FDA.report

SchureMed

Primary DI
00810014601229
Brand
SchureMed
Company
SCHUERCH CORPORATION
Model
800-0342-RF-M
Catalog number
800-0342-RF-M
Device description
GREAT WHITE ROBOTIC STIRRUP WITH FIN --MIZUHO OSI ARMERICA
Published
2019-06-14
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

Related Records

Contact Domains

Product Codes

CodeName
FWZOperating Room Accessories Table Tray

Product Code Classifications

CodeDeviceSpecialtyClass
FWZOperating Room Accessories Table TrayGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810014601229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810014601229008100146012298100146012290810014601229

GMDN Terms

TermDefinition
Heel stirrupA device used during a medical/surgical procedure to steadily hold a patient's foot (feet) by cradling the heel. It is typically attached to an operating table, examination table, or treatment chair and is considered an accessory to these devices. This device is typically constructed of metal and plastic and used in pairs mainly for patients in lithotomic position for obstetrical, urological, colonic, or rectal procedures. This is a reusable device.

Sterilization Methods

Method

Contacts

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 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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