FDA.reportPublic FDA data

nvc

Primary DI
00814008022571
Brand
nvc
Company
NVISION BIOMEDICAL TECHNOLOGIES, INC.
Model
AC-1000T-200
Device description
Instrument, Tamp, Anterior Cervical Interbody Fusion System (ACIF)
Published
2016-05-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXGTamp

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXGTampOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814008022571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814008022571008140080225718140080225710814008022571

GMDN Terms#

Term, Definition table
TermDefinition
Surgical tamp, reusableA hand-held, surgical instrument designed to be used to manually pack tissue or other material during a surgical intervention. It typically consists of a shaft that terminates in a blunt (flat or profiled) tip at the distal end and a handle at the proximal end. It is typically a one-piece instrument made of metal, however some types may employ a synthetic material for the handle (e.g., Tufnol). The surgeon may pack the material by applying hand pressure to the device or by tapping the proximal end with a hammer/mallet. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
210-545-3713diana@nvisionbiomed.com

Regulatory Flags#

DUNS number
047486041
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810005668088TrigonWD-1001C-7002026-04-24
00810005668095TrigonMTP-22-08-002026-04-24
00810005668101TrigonMTP-22-10-002026-04-24
00810005668118TrigonMTP-22-12-002026-04-24
00810005668125TrigonWD-1000T-MWIS2026-04-24
00810005668187TrigonMTP-18-08-002026-04-24
00810135963565TrigonMTP-18-10-002026-04-24
00810135963572TrigonMTP-18-12-002026-04-24
00810005668132TrigonMTP-22-08T-002026-04-23
00810005668149TrigonMTP-22-10T-002026-04-23
00810005668156TrigonMTP-22-12T-002026-04-23
00810135963589TrigonMTP-18-08T-002026-04-23
00810135963596TrigonMTP-18-10T-002026-04-23
00810135963602TrigonMTP-18-12T-002026-04-23
00810135960502Retropsoas ElectrodeELEC1000-042023-10-25
00810135960519Retropsoas ElectrodeELEC1000-062023-10-25
00810135960526Retropsoas ElectrodeELEC1000-082023-10-25
00810135960533Retropsoas ElectrodeELEC1000-102023-10-25
00810135960540Retropsoas ElectrodeELEC21002023-10-25
00810135960557Retropsoas ElectrodeELEC22402023-10-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18257200163557PILLAR SA TiOrthofix US LLCHXG2026-07-17
18257200163564PILLAR SA TiOrthofix US LLCHXG2026-07-17
B8035506760ORTHOMEDORTHO-MED, INC.HXG2026-06-22
00199150076178Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXG2026-06-05
08800322752098AnyPlus®GS Medical Co., Ltd.HXG2026-01-28
08031497003689Mendec® Kypho Set Monolateral 10 mmTECRES SPAHXG2025-12-17
08031497003696Mendec® Kypho Set Monolateral 15 mmTECRES SPAHXG2025-12-17
08031497003702Mendec® Kypho Set Monolateral 20 mmTECRES SPAHXG2025-12-17
08031497003801Mendec® Kypho Set Bilateral 10 mmTECRES SPAHXG2025-12-17
08031497003818Mendec® Kypho Set Bilateral 15 mmTECRES SPAHXG2025-12-17
08031497003825Mendec® Kypho Set Bilateral 20 mmTECRES SPAHXG2025-12-17
08800038029323SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029330SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029347SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029354SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029361SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029378SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029415SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029422SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039407SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039414SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039421SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039438SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039445SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039452SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039469SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039476SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
00841732142206GENERIC Surgical InstrumentsCTL Medical CorporationHXG2025-03-31
00841732166950GENERIC Surgical InstrumentsCTL Medical CorporationHXG2024-11-01
08800038058262SYNTH™ PLUSIMEDICOM CO., LTD.HXG2024-03-25