Impact

Primary DI
00810135963268
Brand
Impact
Company
NVision Biomedical Technologies, Inc.
Model
PP-1000T-032
Device description
PEEK Union Nail 3.0 countersink shaft The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace). The Impact PEEK Union Nail System contains 3.0mm - 4.5mm diameter, 50mm long pins manufactured from HA Enhanced PEEK (ASTM F2026). The implants are designed with strategically placed ridges to improve initial stability and cannulated structure to simplify insertion over a k-wire. Additionally, it was designed to include tantalum pins to ensure optimal imaging visibility for device placement accuracy.
Published
2025-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00810135963268PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810135963268008101359632688101359632680810135963268

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
210-598-5938denisealva@nvisionbiomed.com

Regulatory Flags#

DUNS number
047486041
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810005666855TrigonLD-050004T-282024-02-22
00810005666862TrigonLD-050006T-282024-02-22
00810005666985TrigonLDP-2408-04102024-02-22
00810005666992TrigonLDP-2408-04082024-02-22
00810005667005TrigonLDP-2408-04062024-02-22
00810005667012TrigonLDP-2408-04042024-02-22
00810005667029TrigonLDP-2408-02102024-02-22
00810005667036TrigonLDP-2408-02082024-02-22
00810005667043TrigonLDP-2408-02062024-02-22
00810005667050TrigonLDP-2408-02042024-02-22
00810005667067TrigonLDP-2408-00102024-02-22
00810005667074TrigonLDP-2408-00082024-02-22
00810005667081TrigonLDP-2408-00062024-02-22
00810005667098TrigonLDP-2408-00042024-02-22
00810005667104TrigonLDP-2405-04082024-02-22
00810005667111TrigonLDP-2405-04062024-02-22
00810005667128TrigonLDP-2405-04042024-02-22
00810005667135TrigonLDP-2405-02082024-02-22
00810005667142TrigonLDP-2405-02062024-02-22
00810005667159TrigonLDP-2405-02042024-02-22

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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
00810135963282ImpactNVision Biomedical Technologies, Inc.HXG2025-09-24
08800038029323SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029330SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
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