FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653469321
Brand
AESCULAP
Company
Aesculap AG
Model
OM396R
Catalog number
OM396R
Device description
ADENOTOME SPARE BLADES ONLY SIZE 1
Published
2020-04-23
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
KBHADENOTOME

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBHAdenotomeEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653469321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653469321040386534693214038653469321

GMDN Terms#

Term, Definition table
TermDefinition
AdenotomeA hand-held manual surgical instrument designed to excise hypertrophic lymphoid tissue in the nasopharynx (i.e., pharyngeal tonsils or adenoids) during a procedure known as an adenoidectomy. It is typically a long, slender instrument with cutting blades at the working end, and a handle with a mechanism to operate the blades. It is available in various designs and sizes and may be a one-piece instrument or require the insertion of the blades into the handle. 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
00757770420322Bausch + LombBausch & Lomb IncorporatedKBH2025-07-29
00757770424443Bausch + LombBausch & Lomb IncorporatedKBH2025-07-29
00757770429974Bausch + LombBausch & Lomb IncorporatedKBH2025-07-29
00757770430055Bausch + LombBausch & Lomb IncorporatedKBH2025-07-29
00190776381943MillenniumAvalign Technologies, Inc.KBH2024-04-30
G586E8221210Novo SurgicalNOVO SURGICAL, INC.KBH2023-12-18
G586E8221220Novo SurgicalNOVO SURGICAL, INC.KBH2023-12-18
G586E8221230Novo SurgicalNOVO SURGICAL, INC.KBH2023-12-18
G586E8221240Novo SurgicalNOVO SURGICAL, INC.KBH2023-12-18
G586E8221720Novo SurgicalNOVO SURGICAL, INC.KBH2023-12-18
G586E8221730Novo SurgicalNOVO SURGICAL, INC.KBH2023-12-18
G586E8221740Novo SurgicalNOVO SURGICAL, INC.KBH2023-12-18
00190776352721MillenniumAvalign Technologies, Inc.KBH2023-11-17
00190776049430AvalignAvalign Technologies, Inc.KBH2023-09-28
00190776227999AvalignAvalign Technologies, Inc.KBH2023-09-28
00190776228002AvalignAvalign Technologies, Inc.KBH2023-09-28
00190776228019AvalignAvalign Technologies, Inc.KBH2023-09-28
00190776327194MillenniumAvalign Technologies, Inc.KBH2023-06-23
G22313594910Medetz Surgical InstrumentsMedetz Surgical Instruments LLCKBH2023-06-08
00887482192825Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KBH2022-12-08
00887482192832Symmetry ASPEN SURGICAL PRODUCTS, INC.KBH2022-12-08
00842331170294Novo Surgical Inc. NOVO SURGICAL, INC.KBH2022-11-13
00190660000103Ambler SurgicalAMBLER SURGICAL CORP.KBH2021-01-04
00190660000110Ambler SurgicalAMBLER SURGICAL CORP.KBH2021-01-04
00190660000127Ambler SurgicalAMBLER SURGICAL CORP.KBH2021-01-04
00190660000134Ambler SurgicalAMBLER SURGICAL CORP.KBH2021-01-04
00190660000141Ambler SurgicalAMBLER SURGICAL CORP.KBH2021-01-04
00190660000158Ambler SurgicalAMBLER SURGICAL CORP.KBH2021-01-04
00190660000165Ambler SurgicalAMBLER SURGICAL CORP.KBH2021-01-04
00190660000172Ambler SurgicalAMBLER SURGICAL CORP.KBH2021-01-04