Symmetry Leksell 31-5103

GUDID 00887482036662

Rongeur Regular Curve

SYMMETRY SURGICAL INC.

Neurosurgical rongeur

Primary Device ID	00887482036662
NIH Device Record Key	53ac6afd-6b87-4d0d-a3e4-2adc22daa96e
Commercial Distribution Discontinuation	9999-01-01
Commercial Distribution Status	In Commercial Distribution
Brand Name	Symmetry Leksell
Version Model Number	31-5103
Catalog Number	31-5103
Company DUNS	079641356
Company Name	SYMMETRY SURGICAL INC.
Device Count	1
DM Exempt	true
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	false
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	false
RX Perscription	false
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1 888-364-7004
Email	customerservice@symmetrysurgical.com
Phone	+1 888-364-7004
Email	customerservice@symmetrysurgical.com
Phone	+1 888-364-7004
Email	customerservice@symmetrysurgical.com
Phone	+1 888-364-7004
Email	customerservice@symmetrysurgical.com
Phone	+1 888-364-7004
Email	customerservice@symmetrysurgical.com
Phone	+1 888-364-7004
Email	customerservice@symmetrysurgical.com
Phone	+1 888-364-7004
Email	customerservice@symmetrysurgical.com
Phone	+1 888-364-7004
Email	customerservice@symmetrysurgical.com
Phone	+1 888-364-7004
Email	customerservice@symmetrysurgical.com
Phone	+1 888-364-7004
Email	customerservice@symmetrysurgical.com

Device Dimensions

Length	9 Inch
Width	3 Millimeter
Length	9 Inch
Width	3 Millimeter
Length	9 Inch
Width	3 Millimeter
Length	9 Inch
Width	3 Millimeter
Length	9 Inch
Width	3 Millimeter
Length	9 Inch
Width	3 Millimeter
Length	9 Inch
Width	3 Millimeter
Length	9 Inch
Width	3 Millimeter
Length	9 Inch
Width	3 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887482036662 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K081651

FDA Product Code

HAE	Rongeur, Manual

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00887482036662]

Moist Heat or Steam Sterilization

[00887482036662]

Moist Heat or Steam Sterilization

[00887482036662]

Moist Heat or Steam Sterilization

[00887482036662]

Moist Heat or Steam Sterilization

[00887482036662]

Moist Heat or Steam Sterilization

[00887482036662]

Moist Heat or Steam Sterilization

[00887482036662]

Moist Heat or Steam Sterilization

[00887482036662]

Moist Heat or Steam Sterilization

[00887482036662]

Moist Heat or Steam Sterilization

[00887482036662]

Moist Heat or Steam Sterilization

[00887482036662]

Moist Heat or Steam Sterilization

[00887482036662]

Moist Heat or Steam Sterilization

[00887482036662]

Moist Heat or Steam Sterilization

[00887482036662]

Moist Heat or Steam Sterilization

[00887482036662]

Moist Heat or Steam Sterilization

[00887482036662]

Moist Heat or Steam Sterilization

[00887482036662]

Moist Heat or Steam Sterilization

[00887482036662]

Moist Heat or Steam Sterilization

[00887482036662]

Moist Heat or Steam Sterilization

[00887482036662]

Moist Heat or Steam Sterilization

[00887482036662]

Moist Heat or Steam Sterilization

[00887482036662]

Moist Heat or Steam Sterilization

[00887482036662]

Moist Heat or Steam Sterilization

[00887482036662]

Moist Heat or Steam Sterilization

[00887482036662]

Moist Heat or Steam Sterilization

[00887482036662]

Moist Heat or Steam Sterilization

[00887482036662]

Moist Heat or Steam Sterilization

[00887482036662]

Moist Heat or Steam Sterilization

[00887482036662]

Moist Heat or Steam Sterilization

[00887482036662]

Moist Heat or Steam Sterilization

[00887482036662]

Moist Heat or Steam Sterilization

[00887482036662]

Moist Heat or Steam Sterilization

[00887482036662]

Moist Heat or Steam Sterilization

[00887482036662]

Moist Heat or Steam Sterilization

[00887482036662]

Moist Heat or Steam Sterilization

[00887482036662]

Moist Heat or Steam Sterilization

[00887482036662]

Moist Heat or Steam Sterilization

[00887482036662]

Moist Heat or Steam Sterilization

[00887482036662]

Moist Heat or Steam Sterilization

[00887482036662]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-09-23

On-Brand Devices [Symmetry Leksell ]

00887482036662	Rongeur Regular Curve
00887482021828	LAMINECTOMY RONGEUR FULL NARR
00887482021811	LAMINECTOMY RONGEUR REG NARR
00887482021804	LAMINECTOMY RONGEUR FULL WIDE
00887482021798	LAMINECTOMY RONGEUR REG WIDE
00887482036679	Symmetry® Rongeur, Leksell, 5 mm, Slightly Curved Handle, 9 in, 228 mm
00887482036716	Symmetry® Rongeur, Leksell, Full Curve, Full Curve Handle, 9 in, 8.0 mm
00887482036693	Symmetry® Rongeur, Leksell Bone, Double-Action, 3 mm Jaw, Full Curve Handle, 9 in, 228 mm
00887482036686	Symmetry® Rongeur, Leksell, 8 mm, Slightly Curved Handle, 9 in, 229 mm

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