FDA.reportPublic FDA data

OPEN WIDE

Primary DI
00859938000169
Brand
OPEN WIDE
Company
Specialized Care Company
Model
OWD
Catalog number
OWD
Device description
Mouth Rest Regular
Published
2023-10-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
KBNGAG, MOUTH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBNGag, MouthEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859938000169PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859938000169008599380001698599380001690859938000169

GMDN Terms#

Term, Definition table
TermDefinition
Seizure bite blockA non-sterile device inserted into a patient's mouth for the prevention of oral tissue damage (e.g., the teeth, lips, tongue and buccal mucosa) typically when the patient has convulsions (a seizure) or is undergoing an electroconvulsive therapy (ECT) that will cause nausea or can cause him/her to bite their jaws together. It will also secure a free flow for air and vomit. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
838672889
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859938000039MOLINIMMO-1MMO-12023-12-20
00859938000046OPEN WIDEOWR-SOWR-S2023-10-11
00859938000053OPEN WIDEOWR-MOWR-M2023-10-11
00859938000060OPEN WIDEOWR-LOWR-L2023-10-11
00859938000206OPEN WIDEOWDTOWDT2023-10-11
00859938000213CORBINCA-HVECA-HVE2023-10-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB71210TBS BASICSACME ENTERPRISE.KBN2026-05-22
G149TBSB71220TBS BASICSACME ENTERPRISE.KBN2026-05-22
G14926002A05TBS DentalACME ENTERPRISE.KBN2026-03-02
G1493807205TBS DentalACME ENTERPRISE.KBN2026-03-02
04250676735287McIvor mouth gagSpiggle & Theis Medizintechnik GmbHKBN2025-09-19
04250676735300Dehnhardt mouth gagSpiggle & Theis Medizintechnik GmbHKBN2025-09-19
00194613045401MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613049294MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613049300MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613049317MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613062125MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613088033MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613097981MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613098087MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613098094MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613098117MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613098124MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613114107MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613115432MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613119072MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613119089MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613120269MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613120474MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613120863MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00757770412792Bausch + LombBausch & Lomb IncorporatedKBN2025-07-29
00757770431748Bausch + LombBausch & Lomb IncorporatedKBN2025-07-29
D92810605610MOUTH PROP LARGE ADULT-GRAY W/ HARGIS/MARTIN ATTACHMENTW.H. Holden, Inc.KBN2025-07-22
D92810605810MOUTH PROP ENDENTULOUS, GRAY W/ HARGIS/MARTIN ATTACHMENTW.H. Holden, Inc.KBN2025-07-22
00810123209330Adler Instrument CompanyAdler, Inc.KBN2025-05-23
00810123209347Adler Instrument CompanyAdler, Inc.KBN2025-05-23