FDA.reportPublic FDA data

Vas-Q-Clip

Primary DI
10816537020001
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
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 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
Lot or batch
true
Expiration date on label
true
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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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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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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