FDA.report

SHEA FOAM HEAD SUPPORTSMALL NONSTERILE

Primary DI
00821925019102
Brand
SHEA FOAM HEAD SUPPORTSMALL NONSTERILE
Company
Gyrus Acmi, Inc.
Model
150179
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
ETDTube, Tympanostomy

Product Code Classifications

CodeDeviceSpecialtyClass
ETDTube, TympanostomyEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00821925019102PrimaryGS10

GMDN Terms

TermDefinition
ENT headrestA device designed to be attached to an appropriate operating table to support and stabilize the head of a recumbent patient during an ear/nose/throat (ENT) procedure. The headrest is typically made of metal and synthetic materials that incorporate a cup-shaped, or indented with a central hole, cushion or pad that provides a softer surface for the patient's head to rest in. It is available in various shapes and sizes and will typically include mechanical mechanisms that enable adjustments in relation to the table top. This is a reusable device after appropriate cleaning.

Sterilization Methods

Method

Contacts

PhoneEmail
1(800)262-3540xxx@xxx.xxx

Regulatory Flags

DUNS number
007198742
Device count
1
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
true
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

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00821925043916SOLTIVETFL-FBX150BS2024-08-01
00821925043930SOLTIVETFL-FBX200S2024-08-01
00821925043978SOLTIVETFL-FBX200BS2024-08-01
00821925043992SOLTIVETFL-FBX365S2024-08-01
00821925044074SOLTIVETFL-FBX940S2024-08-01
00821925002074USA Elite SystemEOS-CFR-252024-07-25
00821925002098USA Elite SystemEOS-HCF252024-07-25
00821925002111USA Elite SystemERIS-CF252024-07-25
00821925002128USA Elite SystemERIS-CF272024-07-25
00821925002159USA Elite SystemERLB-7.52024-07-25
00821925002166USA Elite SystemEROS-CF252024-07-25
00821925002173USA Elite SystemEROS-CF272024-07-25
00821925002586Gyrus ACMI1942024-07-25
00821925007482Gyrus ACMIRFG-31152024-07-25
00821925008076Bovie5686012024-07-25
00821925008083Bovie5686042024-07-25
00821925008458Bovie5686052024-07-25
00821925008908Gyrus ACMIG2152-322024-07-25
00821925009523IRRI-FLO I 59200002024-07-25
00821925011427DIEGO703390502024-07-25

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
50853386007089Hummingbird Tympanostomy Tube SystemPRECEPTIS MEDICAL, INCETD2026-01-05
50853386007096Hummingbird Tympanostomy Tube SystemPRECEPTIS MEDICAL, INCETD2026-01-05
20763000870359MicrogelMEDTRONIC XOMED, INC.ETD2025-06-23
20763000870366SheehyMEDTRONIC XOMED, INC.ETD2025-06-23
2076300087037320763000870373MEDTRONIC XOMED, INC.ETD2025-06-23
20763000870380ReuterMEDTRONIC XOMED, INC.ETD2025-06-23
20763000870403SheehyMEDTRONIC XOMED, INC.ETD2025-06-23
20763000870410DonaldsonMEDTRONIC XOMED, INC.ETD2025-06-23
20763000870427ShepardMEDTRONIC XOMED, INC.ETD2025-06-23
20763000870434ShepardMEDTRONIC XOMED, INC.ETD2025-06-23
20763000870441ShepardMEDTRONIC XOMED, INC.ETD2025-06-23
20763000870458ShepardMEDTRONIC XOMED, INC.ETD2025-06-23
20763000870465ShahMEDTRONIC XOMED, INC.ETD2025-06-23
20763000870472ShahMEDTRONIC XOMED, INC.ETD2025-06-23
20763000870502ArmstrongMEDTRONIC XOMED, INC.ETD2025-06-23
20763000870519ArmstrongMEDTRONIC XOMED, INC.ETD2025-06-23
20763000870533DonaldsonMEDTRONIC XOMED, INC.ETD2025-06-23
20763000870540DonaldsonMEDTRONIC XOMED, INC.ETD2025-06-23
20763000870557ArmstrongMEDTRONIC XOMED, INC.ETD2025-06-23
20763000870564GoodeMEDTRONIC XOMED, INC.ETD2025-06-23
20763000870571GoodeMEDTRONIC XOMED, INC.ETD2025-06-23
20763000870588N/aMEDTRONIC XOMED, INC.ETD2025-06-23
20763000870595GoodeMEDTRONIC XOMED, INC.ETD2025-06-23
20763000870601GoodeMEDTRONIC XOMED, INC.ETD2025-06-23
20763000870618PaparellaMEDTRONIC XOMED, INC.ETD2025-06-23
20763000870632PaparellaMEDTRONIC XOMED, INC.ETD2025-06-23
20763000870649PaparellaMEDTRONIC XOMED, INC.ETD2025-06-23
20763000870656ReuterMEDTRONIC XOMED, INC.ETD2025-06-23
20763000870663ReuterMEDTRONIC XOMED, INC.ETD2025-06-23
20763000870670ShepardMEDTRONIC XOMED, INC.ETD2025-06-23