FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653176649
Brand
AESCULAP
Company
Aesculap AG
Model
OG051R
Catalog number
OG051R
Device description
"Separator, slightly curved, 6 1/4"", (160 mm), rounded edge / blade, width: 1,800 mm, non-sterile, reusable"
Published
2020-04-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JYHEXCAVATOR, EAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYHExcavator, EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653176649PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653176649040386531766494038653176649

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manualA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. 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
true
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00757770409396Bausch + LombBausch & Lomb IncorporatedJYH2025-08-18
00757770419784Bausch + LombBausch & Lomb IncorporatedJYH2025-08-18
05010058078307InstrapacROBINSON HEALTHCARE LIMITEDJYH2025-06-18
05010058178304InstrapacROBINSON HEALTHCARE LIMITEDJYH2025-06-18
05010058078314InstrapacROBINSON HEALTHCARE LIMITEDJYH2025-05-21
05010058178311InstrapacROBINSON HEALTHCARE LIMITEDJYH2025-05-21
05060411986916Formby Cerumen Hook & Probe, 178mmDTR MEDICAL LIMITEDJYH2024-10-11
05060411986923Formby Cerumen Hook & Probe, 178mmDTR MEDICAL LIMITEDJYH2024-10-11
00887482039489Symmetry AustinASPEN SURGICAL PRODUCTS, INC.JYH2024-08-15
00887482113332Symmetry AustinASPEN SURGICAL PRODUCTS, INC.JYH2024-08-15
00887482113752Symmetry HouseASPEN SURGICAL PRODUCTS, INC.JYH2024-08-15
00887482114216Symmetry Paparella-HoughASPEN SURGICAL PRODUCTS, INC.JYH2024-08-15
00887482113684Symmetry HoughASPEN SURGICAL PRODUCTS, INC.JYH2024-08-12
09421901970895Rosen Inserter ADEPT MEDICAL LIMITEDJYH2024-04-23
09421902825224Adept Medical Cerumen Management KitADEPT MEDICAL LIMITEDJYH2024-04-19
00888515228092BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYH2024-02-28
00888515228108BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYH2024-02-28
00888515228528BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYH2024-02-28
00888515228535BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYH2024-02-28
00888515228542BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYH2024-02-28
00888515228559BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYH2024-02-28
00888515228931BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYH2024-02-28
00888515229723BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYH2024-02-28
00888515229907BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYH2024-02-28
00888515229914BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYH2024-02-28
00888515230248BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYH2024-02-28
G586E7214140Novo SurgicalNOVO SURGICAL, INC.JYH2023-12-18
00840343720353GEN2SURGIX MEDICAL LLCJYH2023-11-30