FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653178940
Brand
AESCULAP
Company
Aesculap AG
Model
OM048R
Catalog number
OM048R
Device description
ROSER-KOENIG Mouth Gag, 6 1/4", (160 mm), non-sterile, reusable
Published
2020-04-22
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

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
04038653178940PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653178940040386531789404038653178940

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

Regulatory Flags#

DUNS number
315018218
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04038653033997AESCULAPDC230RDC230R2020-06-17
04038653034321AESCULAPDE112RDE112R2020-06-17
04038653034369AESCULAPDE116RDE116R2020-06-17
04038653034376AESCULAPDE117RDE117R2020-06-17
04038653034406AESCULAPDE120RDE120R2020-06-17
04038653034901AESCULAPDE676RDE676R2020-06-17
04046963116194S4 CERVICALFW028UFW028U2020-08-24
04046963794248ELAN 4GA768GA7682020-04-24
04046963935184HI-LINE XXSGE813SUGE813SU2020-04-24
04046963935191HI-LINE XXSGE814SUGE814SU2020-04-24
04046963966362ELAN 4GA767GA7672020-04-24
04046964054907ELAN 4GA715RGA715R2020-04-24
04046964076664AESCULAPGE812SUGE812SU2020-04-24
04046964526213ECCOSGB068RGB068R2020-04-24
04038653177035AESCULAPOG963ROG963R2016-09-23
04038653242962AESCULAPDF262RDF262R2020-06-17
04038653339563AESCULAPJG901JG9012025-03-22
04038653345038AESCULAPJG910JG9102020-05-20
04038653038244AESCULAPDP511RDP511R2020-06-17
04038653038251AESCULAPDP512RDP512R2020-06-17

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
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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