FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653179381
Brand
AESCULAP
Company
Aesculap AG
Model
OM179R
Catalog number
OM179R
Device description
Tongue Depressor, blade, 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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRCINSTRUMENT, ENT MANUAL SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653179381PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653179381040386531793814038653179381

GMDN Terms#

Term, Definition table
TermDefinition
Tongue depressor, surgicalA hand-held surgical instrument designed to displace and maintain the tongue in a fixed position, usually by depressing it towards the floor of the mouth. It is typically a metallic (e.g., high-grade stainless steel) device either with a straight shape, or more frequently smoothly bent at its center (e.g., to a 90? arch). The proximal end is used as a handle, while the distal end (usually serrated and may include holes) is used to depress the tongue. The device is used in oral surgery (e.g., during tonsillectomy). 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046964680878COREHIP EXTENDEDNK1126TNK1126T2020-08-10
04046964681028COREHIP EXTENDEDNK1131TNK1131T2020-08-10
04046964681127COREHIP PRIMARYNK1201KNK1201K2020-08-10
04046964681189COREHIP PRIMARYNK1207KNK1207K2020-08-10
04046964681301COREHIP PRIMARYNK1209KNK1209K2020-08-10
04046964681349COREHIP PRIMARYNK1221KNK1221K2020-08-10
04046964681363COREHIP PRIMARYNK1223KNK1223K2020-08-10
04046964681387COREHIP PRIMARYNK1225KNK1225K2020-08-10
04046964681400COREHIP PRIMARYNK1227KNK1227K2020-08-10
04046964681424COREHIP PRIMARYNK1229KNK1229K2020-08-10
04046964681462COREHIP PRIMARYNK1241KNK1241K2020-08-10
04046964681486COREHIP PRIMARYNK1243KNK1243K2020-08-10
04046964681509COREHIP PRIMARYNK1245KNK1245K2020-08-10
04046964681523COREHIP PRIMARYNK1247KNK1247K2020-08-10
04046964681547COREHIP PRIMARYNK1249KNK1249K2020-08-10
04046963929435NOVOCARTFR719RFR719R2020-08-24
04046963933357NOVOCARTFR651RFR651R2020-08-24
04038653289509NOVOCARTFR661RFR661R2020-08-10
04046963565992NOVOCARTFR660SUFR660SU2020-04-24
04046963939588NOVOCARTFR744RFR744R2020-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091896ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-22
00198506091902ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-22
00198506091971ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-22
00198506093623ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-22
04059453127471Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRC2026-07-16
04059453133809Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRC2026-07-16
04250407786571FENTEXFENTEX medical GmbHLRC2024-08-01
04250407785765FENTEXFENTEX medical GmbHLRC2022-12-15
04250407785772FENTEXFENTEX medical GmbHLRC2022-12-15
04250407785789FENTEXFENTEX medical GmbHLRC2022-12-15
04250407736866FENTEXFENTEX medical GmbHLRC2022-12-12
04250407736873FENTEXFENTEX medical GmbHLRC2022-12-12
04250407737252FENTEXFENTEX medical GmbHLRC2022-12-12
04250407737443FENTEXFENTEX medical GmbHLRC2022-12-12
04250407737559FENTEXFENTEX medical GmbHLRC2022-12-12
04250407737573FENTEXFENTEX medical GmbHLRC2022-12-12
04250407737597FENTEXFENTEX medical GmbHLRC2022-12-12
04250407737610FENTEXFENTEX medical GmbHLRC2022-12-12
04250407737771FENTEXFENTEX medical GmbHLRC2022-12-12
04250407737788FENTEXFENTEX medical GmbHLRC2022-12-12
04250407737856FENTEXFENTEX medical GmbHLRC2022-12-12
04250407738051FENTEXFENTEX medical GmbHLRC2022-12-12
04250407738082FENTEXFENTEX medical GmbHLRC2022-12-12
04250407738099FENTEXFENTEX medical GmbHLRC2022-12-12
04250407738105FENTEXFENTEX medical GmbHLRC2022-12-12
04250407738112FENTEXFENTEX medical GmbHLRC2022-12-12
04250407738174FENTEXFENTEX medical GmbHLRC2022-12-12
04250407738242FENTEXFENTEX medical GmbHLRC2022-12-12
04250407738259FENTEXFENTEX medical GmbHLRC2022-12-12
04250407738266FENTEXFENTEX medical GmbHLRC2022-12-12