FDA.report

AESCULAP

Primary DI
04046964586149
Brand
AESCULAP
Company
AESCULAP, INC.
Model
MA311R
Catalog number
MA311R
Device description
MC IVOR Mouth Gag, frame and 3 retractor blades, non-sterile, reusable
Published
2020-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KBNGAG, MOUTH

Product Code Classifications

CodeDeviceSpecialtyClass
KBNGag, MouthEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046964586149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046964586149040469645861494046964586149

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

Contacts

PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags

DUNS number
082594540
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
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

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04046955741274AESCULAPFK907NBFK907NB2025-08-17
04046955741281AESCULAPFK908NBFK908NB2025-08-17
04046955741298AESCULAPFK909NBFK909NB2025-08-17
04046955741304AESCULAPFK910NBFK910NB2025-08-17
04046955741311AESCULAPFK960NBFK960NB2025-08-17
04046955741328AESCULAPFK913NBFK913NB2025-08-17
04046955741335AESCULAPFK914NBFK914NB2025-08-17
04046955741342AESCULAPFK915NBFK915NB2025-08-17
04046955741359AESCULAPFK916NBFK916NB2025-08-17
04046955741366AESCULAPFK917NBFK917NB2025-08-17
04046955741373AESCULAPFK961NBFK961NB2025-08-17
04046955741380AESCULAPFK962NBFK962NB2025-08-17

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