The Y3 Locking Trochanteric Plating System Y3P-TS35-30

GUDID 07540194006509

Ø3.5 GT Locking screw - 30mm

Pega Medical Inc

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID07540194006509
NIH Device Record Keybe87300e-ebcf-46e4-ab35-c39257fe6d80
Commercial Distribution StatusIn Commercial Distribution
Brand NameThe Y3 Locking Trochanteric Plating System
Version Model NumberY3P-TS35-30
Catalog NumberY3P-TS35-30
Company DUNS257315713
Company NamePega Medical Inc
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(450)688-5144
Emailegarcia@pegamedical.com
Phone+1(450)688-5144
Emailegarcia@pegamedical.com

Device Dimensions

Outer Diameter3.5 Millimeter
Length30 Millimeter
Outer Diameter3.5 Millimeter
Length30 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *keep at room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS107540194006509 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07540194006509]

Moist Heat or Steam Sterilization

[07540194006509]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-01-14
Device Publish Date2018-12-12

On-Brand Devices [The Y3 Locking Trochanteric Plating System]

07540194006516INSTRUMENT & IMPLANT CASE - FULL
07540194006509Ø3.5 GT Locking screw - 30mm
07540194006493Ø3.5 GT Locking screw - 28mm
07540194006486Ø3.5 GT Locking screw - 26mm
07540194006479Ø3.5 GT Locking screw - 24mm
07540194006462Ø3.5 GT Locking screw - 22mm
07540194006455Ø3.5 GT Locking screw - 20mm
07540194006448Ø3.5 GT Locking screw - 18mm
07540194006431Ø3.5 GT Locking screw - 16mm
07540194006424Ø3.5 GT Locking screw - 14mm
07540194006417Ø3.5 GT Locking screw - 12mm
07540194006400Ø3.5 GT Locking screw - 10mm
07540194006394Ø4.5 Distal Locking screw - 50mm
07540194006387Ø4.5 Distal Locking screw - 45mm
07540194006370Ø4.5 Distal Locking screw - 40mm
07540194006363Ø4.5 Distal Locking screw - 35mm
07540194006356Ø4.5 Distal Locking screw - 30mm
07540194006349Ø4.5 Distal Locking screw - 28mm
07540194006332Ø4.5 Distal Locking screw - 26mm
07540194006325Ø4.5 Distal Locking screw - 24mm
07540194006318Ø4.5 Distal Locking screw - 22mm
07540194006301Ø4.5 Distal Locking screw - 20mm
07540194006295Ø4.5 Distal Locking screw - 18mm
07540194006288Ø4.5 Distal Locking screw - 16mm
07540194006271Ø4.5 Distal Locking screw - 14mm
07540194006264Y3 PLATE 285MM - RIGHT
07540194006257Y3 PLATE 235MM - RIGHT
07540194006240Y3 PLATE 185MM - RIGHT
07540194006233Y3 PLATE 135MM - RIGHT
07540194006226Y3 PLATE 285MM - LEFT
07540194006219Y3 PLATE 235MM - LEFT
07540194006202Y3 PLATE 185MM - LEFT
07540194006196Y3 PLATE 135MM - LEFT
07540194006189Ø4.5 Distal Compression screw - 50mm
07540194006172Ø4.5 Distal Compression screw - 45mm
07540194006165Ø4.5 Distal Compression screw - 40mm
07540194006158Ø4.5 Distal Compression screw - 35mm
07540194006141Ø4.5 Distal Compression screw - 30mm
07540194006134Ø4.5 Distal Compression screw - 28mm
07540194006127Ø4.5 Distal Compression screw - 26mm
07540194006110Ø4.5 Distal Compression screw - 24mm
07540194006103Ø4.5 Distal Compression screw - 22mm
07540194006097Ø4.5 Distal Compression screw - 20mm
07540194006080Ø4.5 Distal Compression screw - 18mm
07540194009401Ø4.5 Distal Compression screw - 16mm
07540194009395Ø4.5 Distal Compression screw - 14mm
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