UNI-CLIP 213113ND

GUDID M248213113ND1

The UNI-CLIP STAPLE is designed so that, by widening the diamond shaped opening, mechanical deformation leads to narrowing of the interaxis of the two legs. The surgeon can obtain a true compression, adjustable and controlled with many choice of sizes (11, 12, 13 or 15mm interaxis, and lengths vary from 13 to 20mm). The UNI-CLIP STAPLE is made from Stainless Steel and it is indicated for fixation of bone fractures or for bone reconstruction. It is delivered non sterile.

NEWDEAL

Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable

Primary Device ID	M248213113ND1
NIH Device Record Key	38ad3ec6-1d06-481f-ac3b-8fa20827ea5e
Commercial Distribution Status	In Commercial Distribution
Brand Name	UNI-CLIP
Version Model Number	213113ND
Catalog Number	213113ND
Company DUNS	536935331
Company Name	NEWDEAL
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Device Dimensions

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Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780052449 [Primary]
HIBCC	M248213113ND1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K011716

FDA Product Code

JDR	STAPLE, FIXATION, BONE