FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653053551
Brand
AESCULAP
Company
Aesculap AG
Model
OM663R
Catalog number
OM663R
Device description
"GWYNNE EVANS Tonsil Dissector, 8"", (200 mm), double ended, width: 6 mm, non-sterile, reusable"
Published
2020-04-20
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
KBMDISSECTOR, TONSIL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBMDissector, TonsilEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653053551PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653053551040386530535514038653053551

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery dissectorA hand-held surgical instrument, usually spoon-shaped or rounded at the working end, used to separate a soft tissue or body structure from another. It is used in general or plastic surgery and is usually designed with a handle which continues into a shaft that terminates at the distal end with a tip. The tip may be pointed or flat, sharp or blunt, and angled or straight from the shaft. It is made of high-grade stainless steel, comes in various shapes and sizes. 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
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
04038653013845AESCULAPOP297ROP297R2017-07-31
04038653081141AESCULAPOP913OP9132016-09-23
04038653081158AESCULAPOP914OP9142020-08-10
04038653013852AESCULAPOP298ROP298R2020-04-17
04046963730109AESCULAPOP923OP9232019-04-30
04046955273508AICONJJ612JJ6122022-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04049047003137GimmiGimmi GmbHKBM2026-05-18
09348811101358INKAThe Trustee for KAISER FAMILY TRUSTKBM2025-11-25
00757770404643Bausch + LombBausch & Lomb IncorporatedKBM2025-07-29
00757770411443Bausch + LombBausch & Lomb IncorporatedKBM2025-07-29
00757770421091Bausch + LombBausch & Lomb IncorporatedKBM2025-07-29
00757770427116Bausch + LombBausch & Lomb IncorporatedKBM2025-07-29
00757770435593Bausch + LombBausch & Lomb IncorporatedKBM2025-07-29
04049047679776GimmiGimmi GmbHKBM2025-04-16
00194613120344MSI Precision Specialty InstrumentsMed Saver, Inc.KBM2025-03-21
00194613061692MSI Precision Specialty InstrumentsMed Saver, Inc.KBM2024-08-15
00194613089177MSI Precision Specialty InstrumentsMed Saver, Inc.KBM2024-08-15
00194613094973MSI Precision Specialty InstrumentsMed Saver, Inc.KBM2024-08-15
00840183512309BR Surgical, LLCBR Surgical, LLCKBM2024-06-10
00840183512484BR Surgical, LLCBR Surgical, LLCKBM2024-06-10
00887482049198Symmetry LillieASPEN SURGICAL PRODUCTS, INC.KBM2022-10-13
00887482122839Symmetry HurdASPEN SURGICAL PRODUCTS, INC.KBM2022-10-13
04046826131128MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKBM2020-09-24
04046826131135MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKBM2020-09-24
04046826131142MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKBM2020-09-24
04046826131159MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKBM2020-09-24
04046826131166MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKBM2020-09-24
04046826131173MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKBM2020-09-24
04046826131180MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKBM2020-09-24
M6334167500JEDMEDJEDMED INSTRUMENT COMPANYKBM2020-09-01
04046955088461AESCULAPAESCULAP, INC.KBM2020-08-03
04038653179992AESCULAPAesculap AGKBM2020-04-23
04038653179985AESCULAPAesculap AGKBM2020-04-22
04038653180004AESCULAPAesculap AGKBM2020-04-22
04038653053568AESCULAPAesculap AGKBM2020-04-20
04038653053575AESCULAPAesculap AGKBM2020-04-20