FDA.report

AESCULAP

Primary DI
04046964588167
Brand
AESCULAP
Company
AESCULAP, INC.
Model
MA546R
Catalog number
MA546R
Device description
RONIS Adenoid Cutting Forceps, 8 1/2", (215 mm), (8 mm), triangular shaft, #2
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
KBSPUNCH, ADENOID

Product Code Classifications

CodeDeviceSpecialtyClass
KBSPunch, AdenoidEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046964588167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046964588167040469645881674046964588167

GMDN Terms

TermDefinition
Adenoid punch forcepsA hand-held manual surgical instrument with a cutting/biting action intended to be used for excising adenoid tissue (hypertrophic lymphoid tissue in the nasopharynx) during an adenoidectomy (adenectomy). It is a metallic alligator-forceps-like instrument, often with a curved shaft, and with a distal mechanism designed to bite/punch adenoid tissue when the handles are squeezed together. It is not intended for cutting bone (i.e., not a rongeur). This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

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
false
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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