FDA.report

Novo Surgical Inc.

Primary DI
00842331157134
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
E8371-22
Catalog number
E8371-22
Device description
sage tonsil snare, includes 1 package of 12 snare wires, 25 gauge, 11" (28.0 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
KBZSnare, Tonsil

Product Code Classifications

CodeDeviceSpecialtyClass
KBZSnare, TonsilEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842331157134PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331157134008423311571348423311571340842331157134

GMDN Terms

TermDefinition
Wire ligatureA sterile, thin metal cord intended to be tied tightly around a blood vessel, the pedicle of a tumour, or other structure in order to constrict it. 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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G586NS720155800Novo Surgical IncNS720-1558-0NS720-1558-02025-09-15
00842331192968Novo Surgical IncG1911-38IG-NS2023-08-21
G586N8810500Novo SurgicalN8810-502025-05-19
G586NS38796080NOVOSURGICALNS38-796-08NS38-796-082025-05-02
G586NS50468110Novo SurgicalNS50-4681-1NS50-4681-12025-05-02
G586G171631E0NovosurgicalG1716-31E2025-04-17
G586G311041NC0Novo SurgicalG3110-41NC2025-03-21
G586N697205A0NovosurgicalN6972-05AN6972-05A2025-02-06
G586N697206A0NovosurgicalN6972-06AN6972-05A2025-02-06
G586NS02533010Novo SurgicalNS02-5330-1NS02-5330-12025-02-06
G586NS5230002SPFB10Novo SurgicalNS52-300-02SPFB-1NS02-5330-12025-02-06
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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00757770420629Bausch + LombBausch & Lomb IncorporatedKBZ2025-07-29
00757770433995Bausch + LombBausch & Lomb IncorporatedKBZ2025-07-29
04049047127918GimmiGimmi GmbHKBZ2025-05-21
04049047127925GimmiGimmi GmbHKBZ2025-05-21
00194613104566MSI Precision Specialty InstrumentsMed Saver, Inc.KBZ2025-03-21
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