FDA.report

Novo Surgical Inc.

Primary DI
00842331152610
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
E7214-74
Catalog number
E7214-74
Device description
house hoe-style excavator, 0.5 mm tip angled 90 degrees, straight shaft, 6 1/2" (16.5 cm)
Published
2022-11-12
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
true

Related Records

Contact Domains

Product Codes

CodeName
JYHExcavator, Ear

Product Code Classifications

CodeDeviceSpecialtyClass
JYHExcavator, EarEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842331152610PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331152610008423311526108423311526100842331152610

GMDN Terms

TermDefinition
Ear excavatorA hand-held manual surgical instrument designed for cutting, scraping, scooping and removing tissue during a surgical procedure in or around the ear, allowing the performance of specialized procedures such as removal of the cochlear cupola and microsurgery of the middle ear and the sinus timpani. It is made of high-grade stainless steel and typically designed as a double-ended instrument having a central handle with small and sharp spoon-, scoop-, or spatula-shaped blades that have cutting/gouging edges. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
1877-860-6686info@novosurgical.com

Regulatory Flags

DUNS number
033029433
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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