FDA.report

J&J Instruments

Primary DI
00817524023367
Brand
J&J Instruments
Company
J & J INSTRUMENTS INC
Model
07-900
Device description
MOLT MOUTH GAG W/TIPS CHILD
Published
2019-10-11
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

Product Codes

CodeName
KBNGag, Mouth

Product Code Classifications

CodeDeviceSpecialtyClass
KBNGag, MouthEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817524023367PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817524023367008175240233678175240233670817524023367

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
783328149
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

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00817524026795J&J Instruments33-200033-20002023-03-01
00817524026801J&J Instruments33-303033-30302023-03-01
00817524026818J&J Instruments33-306533-30652023-03-01
00817524026825J&J Instruments33-410033-41002023-03-01
00817524026832J&J Instruments33-415033-41502023-03-01
00817524026849J&J Instruments33-523033-52302023-03-01
00817524026856J&J Instruments33-526033-52602023-03-01
00817524026863J&J Instruments33-615033-61502023-03-01
00817524027532J&J Instruments37-500537-50052023-03-01
00817524027549J&J Instruments37-301037-30102023-03-01
00817524027556J&J Instruments37-302037-30202023-03-01
00817524027563J&J Instruments37-303037-30302023-03-01

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