FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653180257
Brand
AESCULAP
Company
Aesculap AG
Model
OM806R
Catalog number
OM806R
Device description
SLUDER-BALLANGER Tonsil Knife Handle
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
KCATONSILLECTOME

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653180257PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653180257040386531802574038653180257

GMDN Terms#

Term, Definition table
TermDefinition
Nasal snare, reusableA hand-held manual surgical instrument intended to be inserted into the naris for the removal of tissue, typically polyps, tumours, and other abnormal tissue from the nasal cavity during ear/nose/throat (ENT) surgery. It typically consists of a cannula-like tube with two stationary and one sliding finger rings designed to position and tighten a loop of thin, flexible wire (the snare) around the tissue to be removed. It is intended for mechanical cutting only (i.e., not through electrical ablation). 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
00190776228095AvalignAvalign Technologies, Inc.KCA2023-06-23
00190660000042Ambler SurgicalAMBLER SURGICAL CORP.KCA2021-01-04
00190660000059Ambler SurgicalAMBLER SURGICAL CORP.KCA2021-01-04
00190660000066Ambler SurgicalAMBLER SURGICAL CORP.KCA2021-01-04
00190660000073Ambler SurgicalAMBLER SURGICAL CORP.KCA2021-01-04
00190660000080Ambler SurgicalAMBLER SURGICAL CORP.KCA2021-01-04
00190660000097Ambler SurgicalAMBLER SURGICAL CORP.KCA2021-01-04
M6334164410JEDMEDJEDMED INSTRUMENT COMPANYKCA2020-09-01
M63341644110JEDMEDJEDMED INSTRUMENT COMPANYKCA2020-09-01
M63341644120JEDMEDJEDMED INSTRUMENT COMPANYKCA2020-09-01
M63341644130JEDMEDJEDMED INSTRUMENT COMPANYKCA2020-09-01
04038653180226AESCULAPAesculap AGKCA2020-06-17
04038653180233AESCULAPAesculap AGKCA2020-06-17
04038653180240AESCULAPAesculap AGKCA2020-04-23
24026704507515PILLINGTELEFLEX INCORPORATEDKCA2018-09-15
24026704507522PILLINGTELEFLEX INCORPORATEDKCA2018-09-15
24026704507539PILLINGTELEFLEX INCORPORATEDKCA2018-09-15