FDA.reportPublic FDA data

"HEAD RING, GEL, PED, CLOSED, 3.5"" DIA"

Primary DI
00842430113208
Brand
"HEAD RING, GEL, PED, CLOSED, 3.5"" DIA"
Company
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Model
10201
Catalog number
10201
Published
2020-05-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCXSupport, Patient Position

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842430113208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842430113208008424301132088424301132080842430113208

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding headrest, reusableA device designed to be placed on a flat surface (e.g., operating/examination table, stretcher) to support and stabilize the head of a recumbent patient, typically in preparation for and during many types of medical procedures or examinations; it is not attached to a parent device. The headrest is typically made of shock-absorbing materials (e.g., memory foam, gel) that cushion the head and is available in various sizes and shapes including head pad, head ring, and concave ergonomic holders with fingered lateral supports to position the head. This is a reusable device after appropriate cleaning.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-777-4674CustServ@mizuhosi.com

Regulatory Flags#

DUNS number
084527241
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842430117312ADANTE DURABLE BODY STRAP, NO HOOK6895-13656895-13652026-04-17
00842430116667ADANTE PELVIC CENTER POSTLESS PAD6895-13066895-13062025-07-04
00842430116735ADANTE ADAPTER, MAI CLARK SOCKET6895-21906895-21902026-03-31
00842430116766 WELL LEG SUPPORT, SHORT5855-838S5855-838S2026-03-31
00842430116742PKIT, STS Trios, LPC, SG ARM PAD5808PC-12026-01-21
00842430116759PKIT PROAXIS LPC SG HIP ARM6988A-PC-12026-01-21
10842430116749PKIT, STS Trios, LPC, SG ARM PAD5808PC-12026-01-21
10842430116756PKIT PROAXIS LPC SG HIP ARM6988A-PC-12026-01-21
00842430101717TABLE, INSITE684468442020-09-09
00842430107450INSITE TABLE, 230V6844i6844i2020-09-09
00842430107467TABLE, ProFx, 230 VOLT6850i6850i2020-09-09
00842430112102TABLE, ProFx685068502020-09-09
00842430114601TABLE, INSITE, 100V6844J6844J2020-09-08
00842430100017Allegro Imaging Table 120V, 60HZ680068002016-09-13
00842430100024Allegro Imaging Table 220-230V, 50/60HZ6800I6800I2016-09-15
00842430109188PRONECONNECT PROTECTIVE HELMETPC501FHPC501FH2025-08-29
00842430109195PRONECONNECT ADJUSTABLE HELMETPC502AHPC502AH2025-08-29
00842430109201PRONECONNECT COMBO PACK 4L, 3M, 3SPC-COMBOPC-COMBO2025-08-29
00842430109218PRONECONNECT LOW PROFILE MIRRORPC520MPC520M2025-08-29
00842430109225PRONECONNECT ADJUSTABLE MIRRORPC590MPC590M2025-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196413737MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-04-27
10080196413256MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
10080196413485MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
10080196413690MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
07613327632842Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCCCX2025-11-19
07613327632859SageSAGE PRODUCTS, LLCCCX2025-11-19
07613327632866SageSAGE PRODUCTS, LLCCCX2025-11-19
07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCCCX2025-11-19
10197344149834MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-22
10197344149803MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-12
10197344149810MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-12
10197344149827MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-12
G242SB03RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB07SDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB12RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SS03DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB01RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SB05SDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SB10RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS01DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS04DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS05DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS08DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS10DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS11DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS15DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
10197344161034MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-07-28
10197344158768MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-06-30
10197344100392MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-04-05
10080196413805MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-01-22