FDA.reportPublic FDA data

ZOLL-DENTAL

Primary DI
00840105218432
Brand
ZOLL-DENTAL
Company
Zoll-Dental
Model
Z-4539
Device description
Mouth Gag, Denhart
Published
2021-03-10
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

Contact Domains#

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
00840105218432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840105218432008401052184328401052184320840105218432

GMDN Terms#

Term, Definition table
TermDefinition
Mouth gag, adjustable, reusableA mechanical device with adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent placement of an artificial airway or for an oral/dental surgical intervention. Also known as a jaw spreader, it is available in various designs having support structures that force and/or hold the jaws apart; e.g., it may be designed with flat, pivoted blades that angle outward when adjusted; or it may have two parallel plates that move apart with adjustments to a centre screw; or it may have a scissors-like design with pivoted, self-retaining, notched blades at the distal end. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(847)647-1819JEFF@ZOLLDENTAL.COM

Regulatory Flags#

DUNS number
005449822
Device count
1
DM exempt
false
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
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840105223801ZOLL DENTALZ-49352025-08-11
00840105223757ZOLL DENTALGK-TUN-K62025-08-06
00840105223764ZOLL DENTALGK-TUN-K72025-08-06
00840105223771ZOLL DENTALGK-TUN-K82025-08-06
00840105223788ZOLL DENTALGK-TUN-K92025-08-06
00840105223795ZOLL DENTALGK-TUN-K102025-08-06
00840105223740ZOLL DENTALZ-99972025-07-24
00840105223733ZOLLDENTALS-ST22025-03-17
00840105223726ZOLL DENTALZ-73012025-01-29
00840105223672ZOLL DENTALZ-13022024-12-18
00840105223689ZOLL DENTALZ-13032024-12-18
00840105223696ZOLL DENTALZ-47862024-12-18
00840105223702ZOLL DENTALZ-47872024-12-18
00840105223719ZOLL DENTALZ-47902024-12-18
00840105223658ZOLL DENTALZ-52585052024-12-11
00840105223665ZOLL DENTALZ-48205052024-12-11
00840105223641ZOLL DENTALZ-49862024-08-26
00840105223634ZOLL DENTALRET-UofMN-BENT2024-08-01
00840105223573ZOLL DENTALZ-49332024-07-29
00840105223597ZOLL DENTALZ-90322024-07-29

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