UNI-CP UNICP2SET

GUDID 10381780064480

The UNI-CP system includes compression plates, screws, and instruments.The compression plate is indicated for fixation of bone fractures or bone reconstruction. By widening the “eye” on the interaxis of the plate, mechanical deformation leads to narrowing of the interaxis of the two legs and thus provides compression between the two bone fragments to fuse. The rigidity of the “legs” is obtained using the locking system.

NEWDEAL

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable
Primary Device ID10381780064480
NIH Device Record Key1a96bf12-1a3b-4708-8c9a-386acb1ddbad
Commercial Distribution StatusIn Commercial Distribution
Brand NameUNI-CP
Version Model NumberUNICP2SET
Catalog NumberUNICP2SET
Company DUNS536935331
Company NameNEWDEAL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place.

Device Identifiers

Device Issuing AgencyDevice ID
GS110381780064480 [Primary]
HIBCCM248UNICP2SET1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPLATE, FIXATION, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10381780064480]

Moist Heat or Steam Sterilization

[10381780064480]

Moist Heat or Steam Sterilization

[10381780064480]

Moist Heat or Steam Sterilization

[10381780064480]

Moist Heat or Steam Sterilization

[10381780064480]

Moist Heat or Steam Sterilization

[10381780064480]

Moist Heat or Steam Sterilization

[10381780064480]

Moist Heat or Steam Sterilization

[10381780064480]

Moist Heat or Steam Sterilization

[10381780064480]

Moist Heat or Steam Sterilization

[10381780064480]

Moist Heat or Steam Sterilization

[10381780064480]

Moist Heat or Steam Sterilization

[10381780064480]

Moist Heat or Steam Sterilization

[10381780064480]

Moist Heat or Steam Sterilization

[10381780064480]

Moist Heat or Steam Sterilization

[10381780064480]

Moist Heat or Steam Sterilization

[10381780064480]

Moist Heat or Steam Sterilization

[10381780064480]

Moist Heat or Steam Sterilization

[10381780064480]

Moist Heat or Steam Sterilization

[10381780064480]

Moist Heat or Steam Sterilization

[10381780064480]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-07-16
Device Publish Date2015-09-22

Devices Manufactured by NEWDEAL

10381780064381 - B-BOP2024-07-11 In case of severe deformities of the forefoot, the basal osteotomy may be preferable to the distal osteotomy as it promotes a gr
M248119580ND1 - I.CO.S®2024-04-03 The trephine, with a 6.0mm diameter tri shank attachment, is used to core the cortical bone around the 4.0mm compression screw h
M248119590ND1 - I.CO.S®2024-04-03 The trephine, with a 6.0mm diameter tri shank attachment, is used to core the cortical bone around the 6.5mm compression screw h
M248139107ND1 - METIS®2024-02-07 The metatarsal osteotome is used to cut the bone after the pre-cutting stage with the cutting guide, for the insertion of the im
M248529061ND1 - SURFIX®2023-09-18 This K-Wire of diameter 2.5 mm and of length 250 mm is used to guide the instrumentation and the screws.
10381780043317 - BASAL DORSAL PLATE2023-09-18 The Newdeal sterile Basal Dorsal Plate consists of an osteosynthesis plate designed to bridge the tarsometatarsal joints. It is
10381780043324 - BASAL DORSAL PLATE2023-09-18 The Newdeal sterile Basal Dorsal Plate consists of an osteosynthesis plate designed to bridge the tarsometatarsal joints. It is
10381780043331 - BASAL DORSAL PLATE2023-09-18 The Newdeal sterile Basal Dorsal Plate consists of an osteosynthesis plate designed to bridge the tarsometatarsal joints. It is

Trademark Results [UNI-CP]

Mark Image

Registration | Serial
Company
Trademark
Application Date
UNI-CP
UNI-CP
85679898 4308452 Live/Registered
Newdeal
2012-07-18
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