FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653207251
Brand
AESCULAP
Company
Aesculap AG
Model
OG005R
Catalog number
OG005R
Device description
"ROSEN Micro Ear Needle, curved, 6 1/4"", (160 mm), sharp, No. 7, non-sterile, reusable"
Published
2020-04-23
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
KATPERFORATOR, ANTRUM

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653207251PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653207251040386532072514038653207251

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle, reusableA non-sterile, cylindrical-shaped, solid, metal instrument intended to be used to insert and pull suture material through tissue (e.g., skin, fascia, serous, vascular, or other tissue/organ) during surgical stitching of tissues. It is available in various lengths, curvatures, diameters, cross-sectional shapes, and distal end forms; included is the Reverdin type needle with an eye that can be opened and closed with a sliding mechanism on a handle intended to facilitate ease of suturing. This is a reusable device intended to be sterilized prior to use.

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
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
04046964073236AESCULAPAesculap AGKAT2020-04-24
04046964073243AESCULAPAesculap AGKAT2020-04-24
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