FDA.reportPublic FDA data

AESCULAP

Primary DI
04046955213634
Brand
AESCULAP
Company
AESCULAP, INC.
Model
MG329R
Catalog number
MG329R
Device description
FRONTAL SINUS CURETTE CVD 75DEG 3.5X8MM
Published
2020-05-08
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
KAPCURETTE, NASAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAPCurette, NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046955213634PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046955213634040469552136344046955213634

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose curetteA hand-held manual surgical instrument designed for scraping and/or excising tissue from a wide variety of anatomical sites, and includes at least one non-dermal application (i.e., non-dedicated). It is typically made of high-grade stainless steel, available in a variety of shapes and sizes, and has an appropriately-shaped distal end (e.g., cup-, ring-, spoon-like). This is a single-use 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
082594540
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
04046964676628AESCULAPUS399US3992016-09-22
04046964256967AESCULAPUS910US9102016-09-22
05055049000608AESCULAPUS905US9052016-09-22
05055049007423AESCULAPUS906US9062016-09-22
04046955074624AESCULAPFF025RFF025R2019-04-30
04046955074631AESCULAPFF026RFF026R2019-04-30
04046955074648AESCULAPFF027RFF027R2019-04-30
04046955074655AESCULAPFF028RFF028R2019-04-30
04046955074662AESCULAPFF029RFF029R2019-04-30
04046955074716AESCULAPFF086RFF086R2019-04-30
04046955074723AESCULAPFF087RFF087R2019-04-30
04046955074730AESCULAPFF088RFF088R2019-04-30
04046955074792AESCULAPFF136RFF136R2019-04-30
04046955074808AESCULAPFF137RFF137R2019-04-30
04046955074815AESCULAPFF138RFF138R2019-04-30
04046955074822AESCULAPFF690RFF690R2019-04-30
04046955074914AESCULAPFF828RFF828R2019-04-30
04046955074921AESCULAPFF829RFF829R2019-04-30
04046955074938AESCULAPFF830RFF830R2019-04-30
04046955074945AESCULAPFF831RFF831R2019-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811100368INKAThe Trustee for KAISER FAMILY TRUSTKAP2025-11-28
09348811100382INKAThe Trustee for KAISER FAMILY TRUSTKAP2025-11-25
09348811100979INKAThe Trustee for KAISER FAMILY TRUSTKAP2025-11-25
00757770668410Bausch + LombBausch & Lomb IncorporatedKAP2025-08-05
00757770684618Bausch + LombBausch & Lomb IncorporatedKAP2025-08-05
00757770422944Bausch + LombBausch & Lomb IncorporatedKAP2025-07-31
00757770424764Bausch + LombBausch & Lomb IncorporatedKAP2025-07-31
00757770425716Bausch + LombBausch & Lomb IncorporatedKAP2025-07-31
00757770431182Bausch + LombBausch & Lomb IncorporatedKAP2025-07-31
00757770434046Bausch + LombBausch & Lomb IncorporatedKAP2025-07-31
00757770434640Bausch + LombBausch & Lomb IncorporatedKAP2025-07-31
00757770403004Bausch + LombBausch & Lomb IncorporatedKAP2025-07-28
00757770406562Bausch + LombBausch & Lomb IncorporatedKAP2025-07-28
00757770410859Bausch + LombBausch & Lomb IncorporatedKAP2025-07-28
00757770411962Bausch + LombBausch & Lomb IncorporatedKAP2025-07-28
00757770418589Bausch + LombBausch & Lomb IncorporatedKAP2025-07-28
00757770419845Bausch + LombBausch & Lomb IncorporatedKAP2025-07-28
00757770420506Bausch + LombBausch & Lomb IncorporatedKAP2025-07-28
00757770422630Bausch + LombBausch & Lomb IncorporatedKAP2025-07-28
00757770402779Bausch + LombBausch & Lomb IncorporatedKAP2024-11-20
00757770403776Bausch + LombBausch & Lomb IncorporatedKAP2024-11-20
00757770404483Bausch + LombBausch & Lomb IncorporatedKAP2024-11-20
00757770406586Bausch + LombBausch & Lomb IncorporatedKAP2024-11-20
00757770420360Bausch + LombBausch & Lomb IncorporatedKAP2024-11-20
00757770423088Bausch + LombBausch & Lomb IncorporatedKAP2024-11-20
00887482116203Symmetry PaparellaASPEN SURGICAL PRODUCTS, INC.KAP2024-09-05
00887482119358Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KAP2024-09-05
00194613068608MSI Precision Specialty InstrumentsMed Saver, Inc.KAP2024-08-15
00840183527327BR Surgical, LLCBR Surgical, LLCKAP2024-07-16
00840183522537BR Surgical, LLCBR Surgical, LLCKAP2024-06-03