FDA.report

AESCULAP

Primary DI
04046964586712
Brand
AESCULAP
Company
AESCULAP, INC.
Model
MA376R
Catalog number
MA376R
Device description
PAPARELLA Micro Ear Needle, 2 3/4", (70 mm), heavy, #6, 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
KBRNEEDLE, TONSIL SUTURING

Product Code Classifications

CodeDeviceSpecialtyClass
KBRNeedle, Tonsil SuturingEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046964586712PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046964586712040469645867124046964586712

GMDN Terms

TermDefinition
Tonsil dissector, reusableA hand-held surgical instrument, usually spoon-shaped or rounded at the working end, used during the dissection of the tonsils during ear/nose/throat (ENT) surgery. It can be designed in several configurations, e.g., with a shaft that terminates at the distal end with a rounded, curved or angled tip, or it may be double-ended. The tip may be pointed, flat, sharp or blunt and angled or straight from the shaft and may or may not be serrated. It is made of high-grade stainless steel, available in various shapes and sizes, and may include suction capabilities. 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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