FDA.report

Novo Surgical Inc.

Primary DI
00842331131035
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
NS8384.65
Catalog number
NS8384.65
Device description
aspirating needle 5mm diameter, 450mm length, LL-adapter proximal, distal needle 1,8mm ( 15G) diameter
Published
2022-11-10
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
HNMNeedle, Ophthalmic Suturing

Product Code Classifications

CodeDeviceSpecialtyClass
HNMNeedle, Ophthalmic SuturingOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842331131035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331131035008423311310358423311310350842331131035

GMDN Terms

TermDefinition
Airway needleA sterile, sharp bevel-edged, hollow tubular metal instrument typically used to pierce the throat through to the trachea to establish airway patency. It is especially used to perform cricothyroidotomy in emergency cases of respiratory obstruction. It is typically used by emergency medical services (EMS). This is a single-use 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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G5862562529S0Novosurgical25625-29S2025-01-02
G586N6969090NovosurgicalN6969-092025-01-02
G586N6971710NovosurgicalN6971-712025-01-02
G586N6971730NovosurgicalN6971-732025-01-02
G586N6972700NovosurgicalN6972-702025-01-02
G586NS47110610NovosurgicalNS47-1106-12025-01-02

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