FDA.report

AESCULAP

Primary DI
04046964588235
Brand
AESCULAP
Company
AESCULAP, INC.
Model
MA553R
Catalog number
MA553R
Device description
Micro Ear Needle, 4 1/4", (110 mm), 14GA, non-sterile, reusable
Published
2020-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KTETROCAR, ENT

Product Code Classifications

CodeDeviceSpecialtyClass
KTETrocar, EntEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046964588235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046964588235040469645882354046964588235

GMDN Terms

TermDefinition
ENT trocar bladeA rigid, surgical instrument with a sharp pyramidal or conical point used to puncture body cavities during ear/nose/throat (ENT) surgery. It can be assembled and used together with a compatible cannula (not included) filling its lumen, thereby allowing the introduction of this assembly; following puncture, the trocar blade is withdrawn. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags

DUNS number
082594540
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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