FDA.report

AESCULAP

Primary DI
04046964566325
Brand
AESCULAP
Company
AESCULAP, INC.
Model
MA433R
Catalog number
MA433R
Device description
SCHUKNECHT Retractor (Self Retaining), 5 1/8", (130 mm), 3 x 3 prongs, sharp, 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
KALRETRACTOR, ENT

Product Code Classifications

CodeDeviceSpecialtyClass
KALRetractor, EntEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046964566325PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046964566325040469645663254046964566325

GMDN Terms

TermDefinition
ENT stereotactic surgery systemAn assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during ear/nose/throat (ENT) surgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.

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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04046955741373AESCULAPFK961NBFK961NB2025-08-17
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