FDA.reportPublic FDA data

Vas-Q-Clip

Primary DI
30816537020005
Brand
Vas-Q-Clip
Company
NANOVA BIO MATERIALS INC
Model
2231
Catalog number
2231
Device description
Medium-Large Ligation Clips 6 Clips/Cart
Published
2016-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZPCLIP, IMPLANTABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZPClip, ImplantableGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151943000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151943000Vas-Q-ClipNanova Biomaterials, Inc.2016-03-25FZP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20816537020008PackageGS114In Commercial Distribution
30816537020005PackageGS13In Commercial Distribution
40816537020002PackageGS112In Commercial Distribution
10816537020001PrimaryGS10
00816537020004Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081653702000820816537020008
3081653702000530816537020005
4081653702000240816537020002
1081653702000110816537020001
00816537020004008165370200048165370200040816537020004

GMDN Terms#

Term, Definition table
TermDefinition
Ligation clip, synthetic polymer, non-bioabsorbableA sterile, non-metallic, non-bioabsorbable clasp designed to be implanted around a blood vessel or a tissue bundle for permanent occlusion. It is typically made of plastic materials [e.g., polyoxymethylene (POM), commonly known as Delrin] and may be designed with a self-locking catch. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries, but is usually not intended for fallopian tube occlusion. Its non-metallic design makes it more compatible with radiological imaging than metallic clips. A dedicated, disposable clip applier may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height8.69Millimeter

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(573)875-6682support@nanovabio.com

Regulatory Flags#

DUNS number
006084093
Device count
6
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816537023012FiberFIX160129-1160129-12026-06-09
00816537023029FiberFIX160135-1160135-12026-06-09
00816537023036FiberFIX160145-1160145-12026-06-09
00816537023043FiberFIX190145-1190145-12026-06-09
00816537023050FiberFIX190155-1190155-12026-06-09
00816537023067FiberFIX190165-1190165-12026-06-09
00816537023234FiberFIX160125-1160125-12026-06-09
00816537021698FiberFIX90723-12021-08-21
00816537021704FiberFIX90730-12021-08-21
00816537021711FiberFIX90735-12021-08-21
00816537021728FiberFIX90823-12021-08-21
00816537021735FiberFIX90830-12021-08-21
00816537021742FiberFIX90835-12021-08-21
00816537021759FiberFIX90923-12021-08-21
00816537021766FiberFIX90930-12021-08-21
00816537021773FiberFIX90935-12021-08-21
00816537021780FiberFIX91023-12021-08-21
00816537021797FiberFIX91030-12021-08-21
00816537021803FiberFIX91035-12021-08-21
00816537021810FiberFIX91123-12021-08-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04717480902101InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
04717480902149InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
04717480902170InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
04717480902217InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
04717480902293InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
08904255203877MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
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08904255203945MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255203952MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255225503MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
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08904255225527MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255225534MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255225541MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255225558MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
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