FDA.reportPublic FDA data

AESCULAP

Primary DI
04046964073236
Brand
AESCULAP
Company
Aesculap AG
Model
OG074R
Catalog number
OG074R
Device description
"Micro Ear Needle, 6 1/4"", (160 mm), diam. 0,70 mm, non-sterile, reusable"
Published
2020-04-24
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
KATPERFORATOR, ANTRUM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KATPerforator, AntrumEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046964073236PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964073236040469640732364046964073236

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
04038653042586AESCULAPET251RET251R2016-09-23
04046964227547AESCULAPGF058BGF058B2016-09-23
04038653148998AESCULAPDO706RDO706R2020-04-21
04038653105878AESCULAPLS059RLS059R2020-04-21
04038653106080AESCULAPLS099RLS099R2020-04-21
04038653034666AESCULAPDE419RDE419R2020-06-17
04038653034697AESCULAPDE422RDE422R2020-06-17
04038653105977AESCULAPLS084RLS084R2022-07-29
04038653199020AESCULAPXG105RXG105R2021-10-15
04038653199006AESCULAPXG103RXG103R2020-08-24
04038653199013AESCULAPXG104RXG104R2020-08-24
04038653460533AESCULAPXG106RXG106R2020-08-24
04046963000431AESCULAPXG107RXG107R2020-08-24
04046963000448AESCULAPXG108RXG108R2020-08-24
04046963611538AESCULAPXG126RXG126R2020-08-24
04038653109999AESCULAPND118RND118R2020-05-08
04038653110018AESCULAPND121RND121R2020-05-08
04038653110056AESCULAPND125RND125R2020-05-06
04038653201303PROCARTFR600RFR600R2020-04-22
04038653088690AESCULAPFK352RFK352R2020-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04038653051472AESCULAPAesculap AGKAT2020-05-20
04046964073090AESCULAPAesculap AGKAT2020-04-24
04046964073205AESCULAPAesculap AGKAT2020-04-24
04046964073212AESCULAPAesculap AGKAT2020-04-24
04046964073229AESCULAPAesculap AGKAT2020-04-24
04046964073243AESCULAPAesculap AGKAT2020-04-24
04038653207251AESCULAPAesculap AGKAT2020-04-23
04038653176373AESCULAPAesculap AGKAT2020-04-22
04038653176458AESCULAPAesculap AGKAT2020-04-22
04038653176465AESCULAPAesculap AGKAT2020-04-22
04038653176472AESCULAPAesculap AGKAT2020-04-22
10885403114366V. MuellerCAREFUSION 2200, INCKAT2020-04-15
10885403114335V. MuellerSTERIS CORPORATIONKAT2018-09-10
10885403114427V. MuellerSTERIS CORPORATIONKAT2018-09-10
10885403114328V. MuellerSTERIS CORPORATIONKAT2018-09-10
00841036021511N/ABIOMET MICROFIXATION, INCKAT2017-06-16